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HEMODIALYSIS Powered By Docstoc
					Guidelines to the Treatment of Chronic
  Kidney Disease with Hemodialysis
                   in
              Saudi Arabia
                2006
                          Preface
 Guidelines for the management of chronic kidney disease
(CKD) patients by hemodialysis (HD) have been developed
worldwide to help care takers of this population manage their
patients in a better quality conditions. The renal community
in Saudi Arabia may feel that such guidelines are timely
required based on current surveys conducted by the Saudi
Center for Organ Transplantation (SCOT).
 A committee of the distinguished leaders in the field of
Nephrology in Saudi Arabia was formed by the SCOT to
establish the guidelines for the management of CKD patients
by HD and their input is highly appreciated. We included in
this supplement the prominent studies that were carried out in
Saudi Arabia and categorized the guidelines into HD
management in the light of international experience in this
topic. We have already published guidelines about the
management of anemia and bone disease in the HD patients;
that is why we did not include them in the guidelines in this
booklet. We hope that this work guides the dialysis centers in
Saudi Arabia to establish specific protocols for hemodialysis
management and look forward to update them regularly.

                           Faissal A.M. Shaheen MD.,
                           Muhammad Ziad Souqiyyeh MD.,
                          On behalf of the advisory committee
                          for the management of anemia
 Advisory Committee for the Management of
 Anemia in Chronic Kidney disease Patients
Dr. Othman Alfureyh                  Dr. Mohammad Alsulaiman
Division of Nephrology,              Division of Nephrology,
Department of Medicine,              Department of Medicine,
King Faissal Specialist hospital     Armed Forces Hospital
& Research Center,                   Riyadh
Riyadh.
                                     Prof. Jamal Al-Wakeel
Dr. Saeed AlGhamidi                  Division of Nephrology,
Division of Nephrology,              Department of Medicine,
Department of Medicine,              King Kaled University Hospital,
King Faisal Specialist Hospital,     Riyadh.
Jeddah
                                     Dr. Ayman Karkar
Dr. Ali Alharbi                      Division of Nephrology,
Division of Nephrology,              Department of Medicine,
Department Of Medicine,              Dammam Central Hospital,
Security Forces Hospital,            Dammam
Riyadh.
                                     Dr. Ali Lehbi
Dr. Khaled Almeshari                 Division of Nephrology,
Department of Medicine,              Department of Medicine,
King Faissal Specialist hospital     King Faissal Specialist hospital
& Research Center,                   & Research Center,
Riyadh.                              Riyadh.

Dr. Abdulla Alkhader Alsayyari       Dr. Saadi Taher
Division of Nephrology,              Department of Medicine,
Department of Medicine,              King Fahd National Guard hospital
King Fahd National Guard Hospital,   Riyadh.
Riyadh
                           Contents

Topic                                                       Page


Introduction                                                  1
Treatment of CKD patients by hemodialysis in Saudi Arabia     2
Guidelines Statements                                         8
I. Initiation of Hemodialysis                                 9
II. Patients' education                                      13
III. Set-up for Hemodialysis                                 14
IV. Vascular Access for Hemodialysis                         22
V. Adequacy of Hemodialysis                                  39
VI.Common Infections in HD Patients                          46
VII. Cardiovascular Risk Factors in Hemodialysis patients    49
References                                                   52




                                ii
                             Introduction

  Dialysis is a known modality of renal replacement therapy that is
available worldwide. Chronic kidney disease (CKD) patients in the
advanced stages would require dialysis at certain level during stage 5
of the disease. 1 Accurate estimation of the glomerular filtration rate
should be evaluated in the high risk patients such as hypertensive and
diabetic patients, and early CKD stages followed by early referral to
nephrologists not later than stage 2-3 according to the availability of
appropriate resources.2,3 The best methods of estimation of GFR
should be praticed. 4-10Any evidence of malnutrition should be a reason
to start dialysis early if the patient has reached CKD stage 5. 11-15 Other
factors such as hypertension, anemia, dyslipidemia, diabetes, and
derangements of mineral metabolism can affect the progression of
CKD and should be addressed as well.16-21 Perspectives should be
discussed early with patients about the best option of therapy. 22-27
Patients’ education is a very impotant initial step that has enables the
patients to make informed decision for their future.28-32
  The set-up of the dialysis centers involves the personnel and
machinery. Audits about performance of any dialysis center should
take into account the resources available in that center. Respect of the
qualifications and ratios of the different nephrology team members to
the volume of work in any dialysis center is a key to good quality care.
33-49
      The choice of the machines and their maintenance should be
according to the guidelines and best available versions in the market. 50
The quality of the treated water for hemodialysis and design of the
water treatment plants should follow the international standards. 51-58
The choice of the dialyzers and solutions for dialysis have been guided
by many studies that favored the synthetic membranes and bicarbonate
dialysis mode.59-70 The use of anticoagulants during dialysis has been
under great scrutiny since we do not have an ideal agent uptill now
despite the development of the more convenient low molecular weight
heparins.71-76
  The vascular access for hemodialysis has been most time consuming
problem in dialysis units. The creation and maintenance of functioning
access is a major step towards dialysis adequacy.77 The tools for early
detection of inadequate accesses and managements are widely


                                     1
available. These include the measurement of blood flow and pressure
of the accesses, whether it is a graft or fistula.78-81 Temporary accesses
involve catheters of different configurations and insertion sites. 82,83
The catheters as accesses for hemodialysis have always been inferior in
their quality and prognosis to the grafts or fistulae. Early creation of
fistulae is the gold standard practice and audits should follow this
guideline. 84 Guidelines for prevention of infection, steonsis,
thrombosis, and development of aneurysms of accesses should be
established in the dialysis centers and followed strictly to avoid loss of
access that compromises the adequacy of dialysis and may result in
patients’ morbidity and mortality .85-100
  Estimation of adequacy of dialysis depends not only on the accurate
measurement of the small solute clearance such as urea clearance per
unit of body volume (KT/V), but also involves the management of the
patient as a whole such as control of hypertension, anemia and bone
disease. The guidelines for measurement of KT/V and dialysis dose
involve the accurate method of sampling of urea, dialyzer estimated
clearance, time of the dialysis session, and modeling for the solute
clearance (single pool or double pool).101-134
  There are other areas of concen in the management of hemodialysis
patients such as the common infections in the dialysis center. These
include transmittable disease such as viral hepatitis, tuberculosis .135-152
survillance, prophylaxis, prevention, and treatment for these infections
should be guided and maintained in the different dialysis centers.153-157
  The cardiovascular disease in the dialysis patients is of great
importance since it is responsible for the highest percentage of
mortality in population.15 Conventional risk factors such as smoking,
hyperlipidemia, anemia, diabetes, and hypertension can be modified.
Other non-conventional factors such as systemic inflammation
secondary to infectious and non-infectious factors such as oxidative
stresses and homocystein, dialysis membranes, minerals abnormalities
can be modified as well.158-208 Guidelines for control of these factors
should be followed up and addressed by the care takers besides the
other procedures of dialysis.




                                    2
Treatment of CKD patients by Hemodialysis in Saudi Arabia
1. In 1990, al-Mohaya et al209 reported about fistulas in dialysis patients.
    Arterio-venous fistula of Brescia was created in 112 consecutive patients
    during a five year period from May 1983 at King Fahd University Hospital
    of King Faisal University, Al-Khobar, Saudi Arabia.
2. In1990, Mattoo et al210 reported about temporary access for dialysis in
    children.
3. In 1990, Adiku et al 211reported about the concentration of sodium in the
    hemodialysate.
4. In 1990, Shaheen et al212 reported the results of subclavian catheters as
    access for hemodialysis.
5. In 1990, El Tayeb et al213 reported a case of bleeding during dialysis.
6. In 1991, Mahmoud et al214 reported their experience on hemodialysis of
    children in Saudi Arabia.
7. In 1991, Sulimani et al215 repoted about isoniazid induced acute
    confusional state in a patient on hemodialysis.
8. In 1991, Ayoola et al216 reported about the prevalence and significance of
    antibodies to hepatitis C virus among Saudi hemodialysis patients.
9. In 1991, Mitwalli 217reported about tuberculosis in patients on
    maintenance dialysis.
10. In 1991, George et al218 reported a clinical study of permanent vascular
    access in hemodialysis patients.
11. In 1991, Souqiyyeh et al219 reported a case of postpartum hemolytic-
    uremic syndrome.
12. In 1991, Aldrees et al220 reported about the cost evaluation of hemodialysis
    in ministry of health hospitals, Saudi Arabia.
13. In 1992, Souqiyyeh et al221 reported about pregnancy in chronic
    hemodialysis patients in the Kingdom of Saudi Arabia.
14. In 1992, Hussein et al222 reported about the spectrum of pericarditis among
    hemodialysis patients experience in a single center.
15. In 1992, Mahmoud et al 223 reported about the intra-atrial permanent
    catheter: A long-term vascular access for hemodialysis in small children.
16. In 1993, Hussein et al224 reported about the use of biocompatible
    membrane (AN 69) dialyzers in chronic hemodialysis patients.
17. In 1994, Hussein et al225 reported their observations in a Saudi-Arabian
    dialysis population over a 13-year period.
18. Al-Koussi et al226 reported about uremia and hemodialysis effects on
    plasma levels of circulating TNF-.
19. In 1994, Al Shohaib et227 al reported about the complications of subclavian
    catheterization in hemodialysis patients.



                                      3
20. In 1995, Huraib et al228 reported about the high prevalence of and risk
    factors for hepatitis C in hemodialysis patients in Saudi Arabia: a need for
    new dialysis strategies.
21. In 1995, al-Faleh et al229 reported about hepatitis C virus genotypes in
    patients with chronic liver disease and hemodialysis patients from Saudi
    Arabia.
22. In 1995, Ahmad et al230 reported about the prevalence of antibodies
    against the hepatitis C virus among voluntary blood donors at a Makkah
    hospital.
23. In 1995, Al-Muhanna FA.231 Hepatitis C virus infection among
    hemodialysis patients in the eastern region of Saudi Arabia.
24. In 1995, Al Shohaib et al232 reported about the prevalence of hepatitis C
    virus antibodies among hemodialysis patients in Jeddah area, Saudi
    Arabia.
25. In 1995, Bernieh et al233 reported about the prevalence of hepatitis C virus
    antibodies in hemodialysis patients in Madinah Al Munawarah.
26. In 1995, Shaheen et al234 reported about the prevalence of hepatitis C
    antibodies among hemodialysis patients in the Western Province of Saudi
    Arabia.
27. In 1995, Omer et al235 reported about the liver enzymes and protein
    electrophoretic patterns in hemodialysis patients with antibodies against
    the hepatitis C virus.
28. In 1995, Souqiyyeh et al236 reported about the annual incidence of
    seroconversion of antibodies to the hepatitis C virus in the hemodialysis
    population in Saudi Arabia.
29. In 1995, Abu-Aisha et al237 reported about the effect of chemical and heat
    disinfection of the hemodialysis machines on the spread of hepatitis C
    virus infection: A prospective study.
30. In 1995, Qattan et al238 reported about the grafts for hemodialysis access:
    Results and complications.
31. In 1996, Souqiyyeh et al239 reported about the role of computers in
    coordination of renal care facilities: experience in the Kingdom of Saudi
    Arabia.
32. In 1996, Soyannwo et al240 reported about hepatitis C antibodies in
    hemodialysis and pattern of end-stage renal failure in Gassim, Saudi
    Arabia.
33. In 1996 Al-Mugeiren et241 al reported about hepatitis C virus infection in
    two groups of pediatric patients: one maintained on hemodialysis and the
    other on continuous ambulatory peritoneal dialysis.
34. In 1997, Al-Homrany242 reported about successful therapy of tuberculosis
    in hemodialysis patients.




                                      4
35. In 1997, Kumar et al243 reported about acquired cystic renal disease in
    patients receiving long-term hemodialysis.
36. In 1997, Sulaiman 244reported about pregnancy in hemodialysis patients.
37. In 1997, Al-Salman et al245 reported about central vein stenosis in patients
    with prior subclavian vein catheterization for maintenance dialysis.
38. In 1997, Kumar246 reported about hepatitis C virus infection among
    hemodialysis patients in the Najran Region of Saudi Arabia.
39. 1n 1998, Taminu et al247 reported about Doppler ultrasound evaluation of
    hemodialysis vascular access.
40. In 1998, Al-Wakeel248 reported about post-dialysis solutes rebound:
    comparison of two protocols for hemodialysis.
41. In 1999, Al-Homrany et al249 reported about fatal complication of
    percutaneous femoral vein catheterization in a hemodialysis patient.
42. In 1999. Al Shohaib250 reported about tuberculosis in chronic renal failure
    in Jeddah.
43. al-Muhanna et al251 reported about disease profile, complications and
    outcome in patients on maintenance hemodialysis at King Faisal
    University Hospital, Saudi Arabia.
44. In 2000, Mohamed et al252 reported about patients on hemodialysis visiting
    Madina Munawarah: Communication between nephrologists.
45. In 2000, Jamal et al253 reported about nail changes in end-stage renal
    failure patients on hemodialysis.
46. In 2000, Jamal et al254 reported about pruritus among end-stage renal
    failure patients on hemodialysis.
47. In 2000, Tanimu et al255 reported about the effect of vitamin E-modified
    dialyzers on acute intra-dialytic symptoms: a comparative crossover study.
48. In 2000, Al-Salman et al256 reported about effect of arteriovenous fistula
    for hemodialysis on limb circulation.
49. In 2000, Al Shohaib et al257 reported about tuberculous peritonitis in
    hemodialysis patients with chronic liver disease.
50. In 2001, Al-Ghamdi et al 258reported about hepatitis C virus sero-status in
    hemodialysis patients returning from holiday: another risk factor for HCV
    transmission.
51. In 2001, Subramanian et al259 reported about hemodialysis utilization in a
    single in-center dialysis unit in the Kingdom of Saudi Arabia.
52. In 2001, Al-Homrany et al260 reported about psycho-social features of
    chronic dialysis patients in Saudi Arabia: experience of one center.
53. In 2001,Al Dayel et al261 studied the stretch polytetrafluoroethylene grafts
    for hmodialysis agioaccess: Three-year experience.
54. In 2001, Souqiyyeh et al262 reported about dialysis centers in the kingdom
    of Saudi Arabia.




                                      5
55. In 2001,Mitwalli A H., et al263 reported about dialyzer reuse impact on
    dialyzer efficiency, patient morbidity and mortality and cost effectiveness.
56. In 2001, Al-Khader et al264 reported about the need for guidelines for the
    practice of hemodialysis in the Kingdom of Saudi Arabia: a questionnaire
    Survey.
57. In 2002, Saxena et al265 reported about nosocomial transmission of syphilis
    during hemodialysis in a developing country.
58. In 2002, Saxena et al266 reported about outcome of dialysis access-related
    septicemia among diabetics following optimized AV-fistula placement.
59. In 2002, Ayoola EA et al267 Hepatitis E virus infection in hemodialysis
    patients: a case-control study in Saudi Arabia.
60. In 2002, Saeed et al268 reported about the prospective study of
    hemodialysis access-related bacterial infections.
61. In 2002, Dahduli et al269 reported about mobilization and superficialization
    of basilic vein for brachio basilic fistula.
62. In 2002, Bhat et al270 reported about nosocomial infective endocarditis in
    hemodialysis.
63. In 2002, Al Wakeel et al271 reported about morbidity and mortality in
    ESRD patients on dialysis.
64. In 2003, Saxena et al272 reported about impact of dedicated space, dialysis
    equipment, and nursing staff on the transmission of hepatitis C virus in a
    hemodialysis unit of the Middle East.
65. In 2003, Al-Jondeby et al273 reported about comparative crossover
    controlled study using polysulphone and vitamin E coated dialyzers.
66. In 2003, Bouraoui et al274 reported about the predictors of early mortality
    in patients starting chronic hemodialysis.
67. In 2003, Saxena et al275 reported about the prevalence of nasal carriage of
    Staphylococcus aureus and associated vascular access-related septicemia
    among patients on hemodialysis in Al-Hasa Region of Saudi Arabia.
68. In 2003, Al-Jiffri et al276 reported about hepatitis C virus infection
    among patients on hemodialysis in Jeddah: a single center experience.
69. In 2003, Abul Kashem et al277 reported about hepatitis C Virus among
    hemodialysis patients in Najran: Prevalence is more among multi-center
    visitors.
70. In 2003, Souqiyyeh et al278 reported about the attitude of physicians in
    Saudi Arabia towards heparin administration and monitoring in
    hemodialysis patients.
71. In 2004, Saxena et al279 reported about the vulnerability of middle-aged
    and elderly patients to hepatitis C virus infection in a high-prevalence
    hospital-based hemodialysis setting.
72. In 2004, Saxena et al280 reported about the impact of nurse understaffing




                                      6
    on the transmission of hepatitis C virus in a hospital-based hemodialysis
    unit.
73. In 2004, Saxena et al281 reported about advancing age and the risk of nasal
    carriage of Staphylococcus aureus among patients on long-term hospital-
    based hemodialysis.
74. In 2004 Al-Ghamdi282 reported about nurses’ knowledge and practice in
    hemodialysis units: comparison between nurses in units with high and low
    prevalence of hepatitis C virus Infection.
75. In 2004, Raza et al283 reported about the effect of active nutritional
    counseling in improving biochemical nutritional parameters and fluid
    overload problems in maintenance hemodialysis patients.
76. In 2004, Sobki et al284 reported about. effect of age on pituitary gonadal
    hormonal responses of Saudi male patients on hemodialysis.
77. In 2005, Shaheen et al285 reported about a comparative psychosocial
    analysis of patients on maintenance hemodialysis and transplanted
    patients.
78. In 2005, Malik et al286 reported about pregnancy in patients on dialysis
    experience at a referral center.
79. In 2005, Mitwalli et al287 reported about L-Carnitine Supplementation in
    Hemodialysis.
80. In 2005, Badawi et al288 reported about dose and lipid lowering effect of
    tinzaparin sodium: a single center experience.
81. In 2005, Al-Harbi et al289 reported about treatment of acute hepatitis C
    virus infection with alpha interferon in patients on hemodialysis.
82. In 2005, Mohamed290 reported about Morbidity and mortality in ESRD
    patients on regular hemodialysis: a single center experience.




                                       7
GUIDELINES
  STATEMENTS




      8
                 I. Initiation of Hemodialysis

A. Residual renal function should be reported as glomerular filtration
   rate (GFR) and expressed in ml/min/ 1.73 m2 as in in the chonic
   kidney disease patients.
B. Referral to nephrology should be considered when the GFR is ≤60
   ml/min and is mandatory when the GFR is ≤30 ml/min.
C. Dialysis can be initiated when GFR falls below 15 ml/min/1.73 m2
   if there is evidence of uremia or its complications such as
   malnutrition.
D. If there is no evidence of uremia or its complications including
   malnutrition, initiate dialysis when GFR falls below approximately
   10 mL/min/1.73 m2.
E. To encourage informed decision making, educate patients and staff
   about the strength of the evidence (at best, cohort studies) regarding
   the rationale for 'early' dialysis initiation.
F. Monitor GFR quarterly from value of 15-20 ml/min/1.73 m2 and
   monthly from < 15 ml/min/1.73 m2 to avoid unintentional delay in
   initiation of dialysis.
G. With regards to measurement of renal function: GFR calculated as
   the mean of urea and creatinine clearance can be corrected for body
   surface area (BSA) by multiplying the uncorrected GFR
   by1.73/BSA.
H. BSA can be determined from the formula of Du Bois: BSA =
   0.007184 x [height (cm)] 0.725 x [weight (kg)]0.425.
I. Creatinine clearance to determine the need for initiating dialysis
   should not be relied on solely because of the wide variations due to
   extrarenal creatinine clearance and renal creatinine secretion.
J. Target urea clearance can be calculated from the formula: urea clear
   L/wk) = 2.0 (target weekly Kt/V) x Weight (kg) x 0.58
K. V is calculated as (Weight (kg) x 0.58) in this equation. It can be
   more accurately determined from the formulae of Watson :
   1. For males V = 2.477 + [0.3362 x Weight (kg)] + [0.1074 x
       Height (cm)] - [0.09516 x age]
   2. For females V = -2.097 + [0.2466 x Weight (kg)] + [0.1069 x
       Height (cm)]



                                     9
   3. for children V can be calculated using the Mellits-Cheek
      method:
      a) For Boys: V (liters) = -1.927 +0.465*Wt (kg) + 0.045*Ht
         (cm), when Ht < 132.7 cm. V= -21.993 + 0.406* Wt +
         0.209*Ht, when height is > 132.7 cm.
      b) b. For Girls: V = 0.076 + 0.507*Wt + 0.013*Ht, when height
         is < 110.8 cm. V = -10.313 + 0.252* Wt + 0.154*Ht, when
         height is >110.8 cm
L. Primary determinants of mode of initial dialysis include the
   preference of a fully-informed patient, absence of medical and
   surgical contra-indications, and resource availability.
   Peritoneal dialysis contraindications:
   1. Previous abdominal surgery with adhesions
   2. Unrepaired hernia.
   3. Pleuro-peritoneal communication.
   4. Bowel problems (e.g. chronic constipation, diverticulitis).
   5. Severe respiratory insufficiency.
   6. Ileal conduit or colostomy.
   7. Abdominal obesity.
   8. Large muscle mass.
   Hemodialysis contraindications:
   1. Vasculature unsuitable for AV fistula.
   2. Cardiovascular instability.
   3. Needle phobia.
M. When dialysis modality is not determined by preference of a fully-
   informed patient, absence of medical and surgical contraindications
   and resource availability, consider using continuous ambulatory
   peritoneal dialysis (CAPD) in preference to hemodialysis to better
   preserve residual renal function (RRF) and allow graded
   introduction of dialysis.
N. Dialysis should be initiated at first indication of malnutrition
   suspected to be due to uremia and unresponsive to dietary
   intervention or correction of other reversible causes.
O. Evidence of malnutrition should be sought for once a GFR of 15
   mL/min/1.73 m2 is found, and monthly from GFR < 10
   mL/min/1.73 m2.



                                  10
P. Absolute indications' for dialysis initiation is a historical concept,
   which is no longer valid, and their presence suggests delayed
   initiation. However, in some patients with comorbid conditions,
   dialysis may be indicated for these reasons even when GFR is
   greater than 10 mL/min/1.73m2. Traditional absolute indicators
   include:
   1.   Pericarditis.
   2.   Fluid overload.
   3.   Hypertension poorly responsive to non-dialytic treatment.
   4.   Hyperkalaemia.
   5.   Acidosis.
   6.   Advanced uremic encephalopathy and/or neuropathy.
   7.   Significant bleeding diathesis.
   8.   Severe nausea and vomiting.
Q. Similarly, traditional 'relative indications' may not be useful
   because they are largely subjective and depend on patient
   perception and acceptance, and may be due to intercurrent diseases.
   Traditional relative indications include:
   1.   Anorexia.
   2.   Profound fatigue and weakness.
   3.   Impaired cognition, memory and attention span.
   4.   Severe pruritus.
   5.   Depression and poor interpersonal relationships.


R. For patients in nitrogen balance, dietary nitrogen (protein) intake
   (DPI) is equivalent to protein catabolic rate (PCR) + protein losses
   or urinary and non-urinary nitrogen appearance (PNA) + protein
   losses.
S. Approximate normalised PCR (nPCR) may be calculated by the
   Randerson equation :

   1. nPCR (g/kg/d) = {[urea excretion (mmol/d) x 0.209] + 15.71} x
      weight (kg)
   2. For children, plasma nitrogen appearance (PNA) can be derived
      by the modified Borah formula PNA (g/d) = [urea excretion




                                              11
      (mmol/d) x 0.209] + 0.294 x [V (total body water in litres)] +
      protein losses.
T. Corrected DPI can be calculated by multiplying nPCR by
   actual/ideal body weight.
    Malnutrition may be suggested by:

   1.   Fall in lean body mass.
   2.   Fall in serum albumin.
   3.   Serum albumin below the lower limit of the reference range.
   4.   Normalized nPCR < 0.8 g/kg/d.
   5.   Subjective global assessment (SGA).




                                  12
                    II.Patients’ Education

A. Patients and their families or carers should receive sufficient
   information and education regarding the nature of end-stage kidney
   disease (ESKD), and the options for the treatment to allow them to
   make an informed decision about the management of their ESKD.
B. The use of multidisciplinary clinics with input from medical,
   nursing and allied health personnel using standardised protocols for
   the preparation of patients for dialysis is one way of achieving this
   outcome.
C. Predialysis education programmes providing information about
   kidney disease, options for the management of chronic kidney
   disease (CKD) prior to dialysis including:
   1. Pharamacological and dietary management.
   2. The options for renal replacement therapy may also be
      beneficial.
D. Education programmes should incorporate:
   1. A mechanism for the timely referral of patients for the creation
      of an access for dialysis( better control of anemia and
      hypertension).
   2. Greater patient involvement in the selection of the mode of
      dialysis.
   3. A reduction in the need for 'urgent start' dialysis.
   4. Improved short-term survival and quality of life after the
      initiation of dialysis.




                                   13
                    III. Set-up for dialysis
1. Personnel
A. Specialists or consultants in Nephrology. The ratio should be at
   least one physicain to every 50 chronic dialysis patients
   (maximum).
B. Physicians with fewer ratios to patients may take part in the medical
   department activities.
C. The activities of the specialists may include training, audits,
   research and procedures.
D. The minimum expected procedures to be performed by the
   specialists include kidney biopsies and acute access for dialysis.
E. Nurses or dialysis technicians: with a maximum ratio of one nurse
   to every three patients.
F. Dietitian: One to every 100 patients (full time).
G. Social worker: one to every 100 patients (full time).

2. Dialysis Unit design
A. Place should be spacious.Every patient should have at least 7 square
   meters of space for him and his machine. More than 20 machines in
   one unit should be discouraged if possible.

3. Water quality
A. The chemical and bacteriological purity of the dialysis water must
   be monitored routinely and regularly and the results should be
   documented. There should be documented procedures, which come
   into effect once these limits are exceeded. These procedures will
   include temporary closure of the dialysis unit when the safe limits
   for contaminants are exceeded.
B. Ultrapure water may reduce long-term risk of accelerated vascular
   damage, improve response to erythropoetic agents and reduce
   catabolic nutritional state.
C. Infusion fluid for hemodiafiltration or hemofiltration must be
   produced with strict observance of the manufacturer's validated
   process. Final filtration must ensure 7 log reductions in bacterial
   count of ultrapure fluid.
D. European guidelines is preferable to be the basis for optimal




                                 14
     dialysate production than those of the Association for the
     Advancement of Medical Instrumentation (AAMI) guidelines
E.   AAMI guidelines recommendations:
     1. Water: bacterial count < 200 CFU/mL; > 50 CFU/mL warrants
         corrective action.
     2. Endotoxin count < 2 IU/mL; > 1 EU/mL warrants corrective
         action.
     3. Ultrapure: bacterial count < 0.1 CFU/mL; Endotoxin < 0.03
         EU/mL.
F.   European Pharmacopoeia standards:
     1. Water: bacterial count: regular < 100 CFU/mL; ultrapure < 0.1
         CFU/mL (High flux dialysis or on-line fluid production).
     2. Endotoxin count: regular < 0.25 EU/mL; ultrapure < 0.03
         EU/mL.
G.   Monitoring the microbiology of the water feeding dialysis machine
     should be performed weekly during the validation phase and at least
     monthly during the surveillance period
H.   Regular and effective disinfection procedures are an integral part of
     the hygienic maintenance of the water treatment system.
     Periodicity, type of disinfection (chemical, heat, mixed), periodic
     changes of components (filters, resins, filters) should be performed
     in accordance with manufacturer recommendations and adapted to
     microbiology monitoring results. Complete disinfection of the
     water treatment chain should be performed at least monthly.
I.   The most frequently used components are represented by
     mechanical filters, oxidizing filters, cartridge filters, ultrafilters,
     carbon filters, ion exchanger and reverse osmosis units.
J.   Reverse osmosis removes virtually all organic compounds; 90 to
     99% of all ions, and 99.9% of viruses, bacteria and pyrogens.
K.   The allowable chemical contami-nants levels are included in the
     following table:




                                    15
Substance (ppm)       European       AAMI
                      Pharmaco-
Aluminum              poeia
                      0.01           0.01
Ammonium              0.2
Antimony                             0.005
Arsenic                              0.005
Barium                               0.1
Beryl                                0.0004
Cadmium                              0.001
Calcium               2              2
Cyanide                              0.02
Chlorine (free)                      0.5
Chlorine (total)      0.1
Chloramines                          0.1
Chloride              50
Chromium                             0.014
Copper                               0.1
Fluoride              0.2            0.2
Formaldehyde
Magnesium             2              4
Mercury               0.001          0.0002
Nitrate               2              2
Lead                  0.1            0.005
Potassium             2              8
Selenium                             0.09
Silver                               0.005
Sodium                50             70
Sulfate               50             100
Tallium                              0.002
Zinc                  0.1            0.1

L. The key elements to be considered for choosing the most
   appropriate components to include in the water system are the feed
   water contamination levels and the maximum allowed or wished-
   for levels of contaminants in the final product water.
M. Constantly moving water is considered an essential factor to avoid
   bacterial growth; therefore a close loop distribution system
   represents the optimum design.
N. Material used for piping has to offer smooth surfaces and good




                                16
   resistance to the disinfection procedure and to the release of
   chemicals or particles.
O. Polyvinyl chloride (PVC) has been the most used piping material.
   However, the AISI 316L stainless steel, cross-linked polyethylene
   (PEX) or polyvinylidene fluoride (PVDF) offer more advantages
   and are increasingly used.

4. Machines:
A. Machines should be considered for replacement after seven years of
   service or after completing 50,000 hours operation, whichever is
   first.
B. The basic specifications of the dialysis machines: should include
   the following:
   1. The capability of performing bicarbonate hemodialysis and
       bicarbonate variation. Also be able to accept bicarbonate as a
       powder cartrdige.
   2. Automatic control of ultra filtration of fluid ranging from zero to
       2000ml/hour with an ability of performing isolated
       ultrafiltration. Preferably to have volumetric control of
       ultrafiltration.
   3. Built-in heparin pump.
   4. Electronically operated temperature control of dialysate in the
       machine and integrated thermometer with range from 31-42
       degrees centigrade.
   5. Built-in roller blood pump with a flow range of blood from zero
       to at least 400 ml/min with a readable indicator of flow rate. The
       pump should allow manual operation in case of power failure.
   6. Built-in air detection device in venous blood, integrated with
       clamp for venous line, which shuts off automatically upon
       detection of any air bubble or excessive foam.
   7. Built-in blood leak detection unit into the dialysate.
   8. The capability for variation of sodium concentration in the
       dialysate.
   9. Built-in venous and arterial blood pressure sensors with an
       indicator for both pressures.
   10. Built-in conductivity meter with an indicator.
   11. Built-in dialysate flow meter.




                                  17
12. The indicators of the operational status of the different
    parameters should be clearly displayed on the machine.
13. The machine should be a micro processor controlled unit.
14. Built-in facility for standard automatic disinfection procedures.
    Facility for chemical disinfection is a must.
15. To comply with the international electric compatibility (I.E.C).
16. All alarm systems must be of audiovisual type for the following:
    16.1 Power failure.
    16.2 Change of pressure of venous and arterial lines.
    16.3 Air bubbles in blood.
    16.4 Blood leak into dialysate.
    16.5 Temperature change of the dialysate.
    16.6 Change in conductivity of the dialysate.
17. Optional devices in the hemodialysis machine may include:
    17.1 Ability to display the operational status of the dialysis
           machine, parameters, and instructions to the operator of
           the machine on an electronic screen.
    17.2 Capability to perform hemo-filtration mode of therapy.
    17.3 Ability for monitoring of the patient blood pressure
           continuously, while the patient is on dialysis.
    17.4 To have expanded memory for stored data about the
           patients conditions.
    17.5 Capability for programmable ultrafiltration profiling.
    17.6 Capability to have profiling of sodium in the dialysis
           (programming).
    17.7 Preferably to have blood temperature profiling module.
    17.8 Preferably to have a module to measure vascular access
           recirculation and/or access blood flow.
    17.9 Preferably to have capacity for on-line production of
           hemodia-filtrate for hemodia-filtration mode.
    17.10 Preferably to have on-line blood volume monitor (Crit-on-
           line).
    17.11 Preferably to have on-line clearance monitor depending
           on conductivity of sodium or urea sensoring.
    17.12 Preferably to have ability to measure Hemoglobin of the
           patient during the dialysis.
    17.13 Preferably to be able to measure/calculate KT/V of the




                                18
              patient.
   18. Hemodialysis machines that can perform single needle dialysis
       should be available in a ratio not more than 5% in any dialysis
       unit and as an emergency measure for dialysis.
   19. The basic specifications for dialysis chairs for patients should
       include the following:
       19.1 The chair should be manufactured of a rust proof material
              which is easy to clean and sterilize. There should be
              attached cushion.
       19.2 The width should range between 55 and 70cm.
       19.3 It must be both electrically and manually operable.
       19.4 There should be a provision to make it flat like a bed.
       19.5 Head and foot segments of the chair must be movable
              both together and independently.
       19.6 There should be provision to adjust the height of the chair.
       19.7 The arm rests must be movable both horizontally and
              vertically.
       19.8 There should be provision to palace a patient in the
              trendelebergh position while using the chair.
       19.9 To have 110-220 voltage and 60 Hz driving motor and if
              unavailable to be able to match the electricity of the
              dialyser center.

5. Dialyzer Membranes
A. Dialyzer membranes with the lowest degree of complement and
   leukocyte activation should be applied. Dialyzer membranes that
   induce strong complement and leukocyte activation, inflammatory
   reactions, and/or a blunting of the response of leukocytes to stimuli
   should be avoided.
B. Differences in thrombogenicity should be considered in the choice
   of the dialyzer
C. In order to prevent the release of fragments (solid or soluble) from
   the dialyzer circuit, and their accumulation in several organs of the
   body, adequate dialyzer pre-rinsing according to the manufacturers
   instructions should be performed. If no manufacturer instructions
   are given, the dialyzers should be pre-rinsed using at least 2 L of
   rinsing solution. Over-occlusion of the roller pumps should be




                                   19
     avoided as well.
D.   Careful consideration should be given to the use of high-flux
     membranes for patients expecting prolonged dialysis (> 5 years).
E.   Use of dialyzers and tubings sterilized with EtO should be avoided,
     especially in patients showing otherwise unexplained signs of
     anaphylactoid reaction, eosinophilia or elevated IgE. Sterilization
     by steam or γ radition is becoming more popular.
F.   Reuse of dialysers should not be practiced due to its many
     disadvantages.
G.   The combination of dialysis with AN69 membranes and medical
     treatment with ACE-inhibitors (ACE-i) should be avoided because
     of the possibility of severe hemodynamic reactions.
H.   Shear stress-related problems of hemolysis can be prevented by:
     1. The use of large fistula needles/cannulae of 15-16 gauges.
     2. The application of an optimal relationship between dialyzer
         blood flow and access diameter.
     3. The prevention of highly negative arterial pressure alarms
         (exceeding 150 mmHg).
     4. The correct positioning of cannulae and needles in the access
         system.
     5. The correct positioning of tubings in the roller pumps.
     6. Minimizing recirculation.
     7. The maintenance of vascular access systems in anatomically
         correct condition.

6. Dialysate properties
A. The dialysate should contain bicarbonate as the buffer.
B. Bicarbonate concentrate must be handled with care to prevent
   bacterial contamination after container opening. The use of already
   opened containers should be discouraged.
C. Ready for use powder cartridges are the prefered method to deliver
   bicardonate during dialysis than the prepared batch of dissolved
   bicarbonate.
D. Hypoglycemia is not seen if the dialysate contains glucose, but
   glucose-containing dialysate is slightly more expensive.




                                  20
7. Anticoagulants Use in Hemodialysis
A. No clear differences in hemodialysis (LMWHs) adequacy results
   have been demonstrated using standard unfractionated heparin and
   LMWHs.
B. No differences in dialysis adequacy results are achieved using
   different LMWHs.
C. There is no clear difference in the risk of thrombosis or hemorrhage
   with LMWHs compared with standard heparins, although the
   results of individual studies have been quite variable.
D. LMWHs have been suggested to have a number of other potential
   benefits with regard to bleeding risk, anticoagulant efficacy, risk of
   heparin-induced-thrombocytopaenia and lipid profile. These
   benefits remain unproven in patients on dialysis, with inconclusive
   and sometimes conflicting data available from randomized
   controlled trials
E. LMWHs are simpler and more convenient to use given their once-
   only bolus method of administration; this may be an important
   consideration for some centres and some groups of patients.
F. This convenience of LMWHs is balanced by the substantially
   higher cost of these agents compared with unfractionated heparin.
   Until more data directly comparing the two becomes available,
   individual units should make a decision based on whether the extra
   cost can be justified by the issues of convenience.
G. LMWHs have a limited duration of action, so a single bolus
   injection may not provide adequate anticoagulation for long dialysis
   sessions (e.g. overnight dialysis).




                                   21
         IV. Vascular Access for Hemodialysis
1. Vascular Access Placement
A. To determine the type of access most suitable for an ESRD patient,
   a history must be taken and physical examination of the patient's
   venous, arterial, and cardiopulmonary systems must be performed.
   Diagnostic evaluation should be performed when indicated based
   on patient history or physical examination.
B. Venography prior to placement of access is indicated in patients
   with the following:
   1. Edema in the extremity in which an access site is planned.
   2. Collateral vein development in any planned access site.
   3. Differential extremity size, if that extremity is contemplated as
       an access site.
   4. Current or previous subclavian catheter placement of any type in
       venous drainage of planned access.
   5. Current or previous transvenous pacemaker in venous drainage
       of planned access.
   6. Previous arm, neck, or chest trauma or surgery in venous
       drainage of planned access.
   7. Multiple previous accesses in an extremity planned as an access
       site.
C. Additional or alternate imaging techniques are indicated in selected
   cases where multiple previous vascular accesses have been placed,
   or when residual kidney function makes contrast studies
   undesirable. Appropriate techniques include:
   1. Doppler ultrasound.
   2. Magnetic resonance imaging.
D. Arteriography or Doppler examination is indicated when arterial
   pulses in the desired access location are markedly diminished.
E. The order of preference for placement of AV fistulae in patients
   with kidney failure who will become hemodialysis dependent is:
   1. A wrist (radial-cephalic) primary AV fistula.
   2. An elbow (brachial-cephalic) primary AV fistula.
F. If a primary AV fistula cannot be established, a synthetic AV graft
   is the next preferred type of vascular access.
   1. Polytetrafluoroethylene (PTFE) tubes are preferred over other




                                  22
      synthetic materials.
   2. There is no convincing evidence to support tapered over uniform
      tubes, externally supported over unsupported grafts, thick-
      versus thin-walled configurations, or elastic versus nonelastic
      material.
   3. Grafts may be placed in straight, looped, or curved
      configurations. Designs that provide the most surface area for
      cannulation are preferred.
   4. Location of graft placement is determined by each patient's
      unique anatomical restrictions, the surgeon's skill, and the
      anticipated duration of dialysis.
G. Tunneled cuffed venous catheters are the method of choice for
   temporary access of longer than 3 weeks' duration. They also are
   acceptable for access of shorter duration.The indications for
   tunneled catheters include:
   1. Some patients who have exhausted all other access options
   2. Patients who have a primary AV fistula maturing but need
      immediate hemodialysis.
H. The preferred insertion site for tunneled cuffed venous dialysis
   catheters is the right internal jugular vein. Other options include:
   the right external jugular vein, the left internal and external jugular
   veins, subclavian veins, femoral veins, or trans- lumbar access to
   the inferior vena cava.
   1. Subclavian access for tunneled cuffed venous dialysis catheters
      should be used only when jugular options are not available.
   2. Tunneled cuffed catheters should not be placed on the same side
      as a maturing AV access, if possible.
   3. Fluoroscopy or real-time ultrasound-guided insertion is
      mandatory for insertion of all cuffed dialysis catheters. The
      catheter tip should be adjusted to the level of the caval atrial
      junction or into the right atrium to ensure optimal blood flow.
      Atrial positioning is only recommended for catheters composed
      of soft compliant material, such as silicone.
I. There is currently no proven advantage of one cuffed catheter
   design over another. Catheters capable of a rapid blood flow rate
   are preferred. Catheter choice should be based on local experience,
   goals for use, and cost.




                                    23
J. Hemodialysis access of less than 3 weeks' duration should be
   obtained using a non- cuffed, or a cuffed, double-lumen
   percutaneously inserted catheter:
   1. These catheters are suitable for immediate use and should not be
      inserted before needed.
   2. Noncuffed catheters can be inserted at the bedside in the
      femoral, internal jugular, or subclavian position.
   3. The subclavian insertion site should not be used in a patient who
      may need permanent vascular access due to the risk of central
      venous stenosis.
   4. Chest x-ray is mandatory after subclavian and internal jugular
      insertion prior to catheter use to confirm catheter tip position at
      the caval atrial junction or the superior vena cava and to exclude
      complications prior to starting hemodialysis.
   5. Where available, ultrasound should be used to direct insertion of
      these catheters into the internal jugular position to minimize
      insertion-related complications.
   6. Femoral catheters should be at least 19-cm long to minimize
      recirculation. Noncuffed femoral catheters should not be left in
      place longer than 5 days and should be left in place only in bed-
      bound patients.
   7. Nonfunctional noncuffed catheters can be exchanged over a
      guidewire or treated with urokinase or tissue plasminogen factor
      as long as the exit site and tunnel are not infected.
   8. Exit site, tunnel tract, or systemic infections should prompt the
      removal of noncuffed catheters.
K. Arm veins suitable for placement of vascular access should be
   preserved, regardless of arm dominance.
   1. Arm veins, particularly the cephalic veins of the nondominant
      arm, should not be used for venipuncture or intravenous
      catheters.
   2. The dorsum of the hand should be used for intravenous lines in
      patients with chronic kidney disease. When venipuncture of the
      arm veins is necessary, sites should be rotated.
   3. Instruct hospital staff, patients with progressive kidney disease
      (creatinine >300 µmol/L), and all patients with conditions likely
      to lead to ESRD to protect the arms from venipuncture and




                                  24
       intravenous catheters.
   4. An alert bracelet may be worn to inform hospital staff to avoid
       IV cannulation of essential veins.
L. Patients with chronic kidney disease should be referred for surgery
   to attempt construction of a primary AV fistula when their
   creatinine clearance is <25 mL/min (stage 4 CKD).
   1. The patient should be referred to a nephrologist prior to the need
       for access to facilitate kidney failure treatment and for
       counseling about modes of ESRD care, including hemodialysis,
       peritoneal dialysis, and renal transplantation.
   2. A new primary fistula should be allowed to mature for at least 1
       month, and ideally for 3 to 4 months, prior to cannulation.
   3. Dialysis AV grafts should be placed at least 3 to 6 weeks prior
       to an anticipated need for hemodialysis in patients who are not
       candidates for primary AV fistulae.
   4. Hemodialysis catheters should not be inserted until hemodialysis
       is needed.
   5. A primary AV fistula is mature and suitable for use when the
       vein's diameter is sufficient to allow successful cannulation, but
       not sooner than 1 month (and preferably 3 to 4 months after
       construction.
M. Maturation of AV fistulae can be enhanced by:
   1. Fistula hand-arm exercise (eg, squeezing a rubber ball with or
       without a lightly applied tourniquet) will increase blood flow
       and speed maturation of a new native AV fistula.
   2. Selective obliteration of major venous side branches will speed
       maturation of a slowly maturing AV fistula.
   3. When a new native AV fistula is infiltrated (ie. presence of
       hematoma with associated induration and edema), it should be
       rested until swelling is resolved.
N. PTFE dialysis AV grafts should not routinely be used until 14 days
   after placement.
   1. Cannulation of a new PTFE dialysis AV graft should not
       routinely be attempted, even 14 days or longer after placement,
       until swelling has gone down enough to allow palpation of the
       course of the graft. Ideally, 3 to 6 weeks should be allowed prior
       to cannulation of a new graft.




                                   25
   2. Erythema of a new dialysis AV graft should not prevent its use,
      as long as the redness is limited to the path of the graft.
      Erythema along the path of the graft suggests surgical
      inflammation rather than infection.
   3. Patients with swelling that does not respond to arm elevation or
      that persists beyond 2 weeks after dialysis AV access placement
      should receive a venogram or other noncontrast study to
      evaluate central veins.
O. Cuffed and noncuffed hemodialysis catheters are suitable for
   immediate use and do not require maturation time.

2. Monitoring, Surveillance, and Diagnostic Testing
A. Monitoring refers to the examination and evaluation of the vascular
   access by means of physical examination to detect physical signs
   that would suggest the presence of pathology.
B. Physical examination of an access graft should be performed
   weekly and should include, but not be limited to, inspection and
   palpation for pulse and thrill at the arterial, and venous sections of
   the graft.
C. Data from the clinical assessment and dialysis adequacy
   measurements should be collected and maintained for each patient's
   access and made available to all staff. The data should be tabulated
   and tracked within each dialysis.
D. Surveillance refers to periodic evaluation of the vascular access by
   means of tests that may involve special instrumentation, for which
   an abnormal test result suggests the presence of pathology.
E. Diagnostic Testing refers to testing that is prompted by some
   abnormality or other medical indication, and which is undertaken to
   diagnose the presence of pathology.
F. Access flow measured by ultrasound dilution, conductance dilution,
   thermal dilution, Doppler or other technique should be performed
   monthly.
   1. The assessment of flow should be performed during the first 1.5
      hours of the dialysis session to eliminate error caused by
      decreases in cardiac output related to ultrafiltration.
   2. The mean value of 3 separate determinations performed at a
      single treatment should be considered the access flow.




                                   26
G. AV graft and AV fistula access flow less than 600 mL/min, the
   patient should be referred for fistulogram.
H. Access Flow less than 1,000 mL/min that has decreased by more
   than 25% over 4 months should be referred for fistulogram.
I. Prospective surveillance of AV grafts for hemodynamically
   significant stenosis, when combined with correction, improves
   patency and decreases the incidence of thrombosis. Techniques, not
   mutually exclusive that can be used in surveillance for stenosis in
   AV grafts include, in order of decreasing preference:
   1. Intra-access flow.
   2. Static venous dialysis pressure.
   3. Dynamic venous pressures.
   4. Measurement of access recirculation using urea concentrations.
   5. Measurement of recirculation using dilution techniques (non-
      urea-based).
   6. Unexplained decreases in the measured amount of hemodialysis
      delivered.
   7. Physical findings of persistent swelling of the arm, clotting of
      the graft, prolonged bleeding after needle withdrawal, or altered
      characteristics of pulse or thrill in a graft.
   8. Elevated negative arterial pre-pump pressures that prevent
      increasing to acceptable blood flow.
   9. Doppler ultrasound,
J. Persistent abnormalities diagnostic testing in AV grafts in any of
   these parameters should prompt referral for venography.
K. All patients should be taught how to:
   1. Compress a bleeding access.
   2. Seal the site of a central venous catheter (CVC) with ointment to
      keep air embolus from entering.
   3. Wash skin over access with soap and water daily and before
      dialysis.
   4. Recognize signs and symptoms of infection.
   5. Select proper methods for exercising AV fistula arm with some
      resistance to venous flow.
   6. Palpate for thrill/pulse daily and after any episodes of
      hypotension, dizziness, or lightheadedness.
   7. Listen for bruit with ear opposite access if cannot palpate for any




                                     27
       reason,
   8. Avoid carrying heavy items draped over the access arm or
       wearing occlusive clothing.
   9. Avoid sleeping on the access arm.
   10. Insist that staff rotate cannulation sites daily.
   11. Insure that all staff use proper techniques in preparing skin prior
       to cannulation.
   12. Report any signs and symptoms of infection or absence of
       bruit/thrill to dialysis personnel immediately.
L. Intervention with percutaneous transluminal angioplasty (PTA) or
   surgical revision to correct stenoses dramatically reduces the rate of
   AV graft thrombosis and loss.
M. Sequential timely repetitive measurement of access flow is the
   preferred method for surveillance of AV grafts.
N. Doppler flow, ultrasound dilution, and magnetic resonance have
   been the most extensively evaluated. All require specialized devices
   and some are expensive such as the magnetic resonance.
O. Although Doppler studies can be predictive of access stenosis and
   the likelihood for failure, inter-observer variability in measurement
   of Doppler can reduce the reliability of Doppler flow measurement.
   Variation in Doppler flow measurements performed by machines
   produced by different manufacturers also occurs.
P. Both Doppler flow and magnetic resonance are difficult to perform
   during dialysis sessions. In contrast, flow measurements performed
   by ultrasound velocity and other techniques using blood dilution are
   reliable and valid and can be done on-line during dialysis, thereby
   providing rapid feedback.
Q. Trends in either dynamic or static venous dialysis pressure
   measurements are more predictive of access stenosis than any
   single pressure measurement.
R. Unexplained decreases in delivered dialysis dose, as measured by
   Kt/V or URR, are frequently associated with venous outflow
   stenoses. However, many other factors influence Kt/V and URR,
   making them less sensitive and less specific for detecting access
   dysfunction.
S. Recirculation should be measured using a nonurea-based dilutional
   method or by using the two-needle urea-based method.




                                    28
T. The three-needle peripheral vein method of measuring recirculation
   should not be used.
U. Any access recirculation is abnormal. Recirculation exceeding 10%
   using the recommended two-needle urea-based method, or 5%
   using a nonurea-based dilutional method, should prompt
   investigation of its cause.
V. If access recirculation values exceed 20%, correct placement of
   needles should be confirmed before conducting further studies.
W. Elevated levels of access recirculation should be investigated using
   angiography (fistulography) to determine whether stenotic lesions
   are impairing access blood flow.

3. Prevention of Infection
 Staff and patient education should include instruction on infection
control measures for all hemodialysis access sites.
A. All dialysis staff should be trained in infection control procedures.
B. Documenting educational materials and objectives must be part of
   the patient's records and staff orientation records in terms of
   catheter care and accessing the patient's circulation.
C. Tracking the occurrence of infections can help identify the source
   and allow corrective action to be taken. Ongoing quality assurance,
   risk management, or CQI efforts should be in place to monitor the
   incidence of infection, to evaluate the response to patient and staff
   education, and to identify future educational needs.
D. A clean technique for needle cannulation should be used for all
   cannulation procedures.
   1. Locate and palpate the needle cannulation sites prior to skin
       preparation.
   2. Wash access site using an antibacterial soap or scrub (eg, 2%
       chlorhexidine) and water.
   3. Cleanse the skin by applying 70% alcohol and/or 10% povidone
       iodine using a circular rubbing motion.
   4. Alcohol has a short bacteriostatic action time and should be
       applied in a rubbing motion for 1 minute immediately prior to
       needle cannulation.
   5. Povidone iodine needs to be applied for 2 to 3 minutes for its
       full bacteriostatic action to take effect and must be allowed to




                                   29
       dry prior to needle cannulation.
   6. Clean gloves should be worn by the dialysis staff for
       cannulation. Gloves should be changed if contaminated at any
       time during the cannulation procedure.
   7. New, clean gloves should be worn by the dialysis staff for each
       patient.
   8. After skin preparation, skin should be pulled tight in opposite
       direction of needle insertion.
   9. Approximately 45 degree angle of insertion should be used for
       AV graft and approximately 25 degree angle for AV fistula.
   10. Once the vessel has been penetrated, there are basically three
       methods employed in practice:
       10.1 Advance the needle slowly with cutting edge facing top of
              vessel and do not rotate axis.
       10.2 Immediately rotate the axis of the needle 180 degrees and
              advance slowly with cutting edge facing bottom of the
              vessel.
       10.3 Advance the needle to desired position, and then rotate the
              axis 180 degrees.
   11. Tape the needle at the same angle or one similar to the angle of
       insertion.
   12. Remove needle at same or angle similar to angle of insertion,
       and never apply pressure before the needle is completely out.
F. For catheter care and accessing the patient's circulation should be
   clean procedures.
   1. Hemodialysis catheter dressing changes and catheter
       manipulations that access the patient's bloodstream should only
       be performed by trained dialysis staff.
   2. The catheter exit site should be examined at each hemodialysis
       treatment for signs of infection.
   3. Catheter exit site dressings should be changed at each
       hemodialysis treatment.
   4. Use of dry gauze dressing combined with skin disinfection,
       using either chlorhexidine or povidone iodine solution, followed
       by povidone iodine ointment or mupirocin ointment at the
       catheter exit site are recommended after catheter placement and
       at the end of each dialysis session.




                                 30
5. Manipulating a catheter and accessing the patient's bloodstream
    should be performed in a manner that minimizes contamination.
6. During catheter connect and disconnect procedures, nurses and
    patients should wear a surgical mask or face shield. Nurses
    should wear gloves during all connect and disconnect
    procedures. Also these precautions should be adopted for all
    catheter dressing changes.
7. The catheter hub caps or blood line connectors should be soaked
    for 3 to 5 minutes in povidone iodine and then allowed to dry
    prior to separation, or to use new hub caps.
8. Catheter lumens should be kept sterile.To prevent
    contamination, lumens and tips should never remain open to air.
    A cap or syringe should be placed on or within the catheter
    lumen, while maintaining a clean field under the catheter
    connectors.
9. In patients with an allergy to povidone iodine, alternate agents
    such as polyan-tiraicrobial gel can be substituted. Catheter
    infection can occur following transmission of hand or
    aerosolized bacterial contaminants.
10. Staphylococcus aureus is the leading cause of catheter exit site
    infection and bacteremia in hemodialysis patients. Bacteremia
    and tunnel tract infections are the leading causes of catheter loss.
11. Chronic hemodialysis patients are at increased risk of S aureus
    nasal carriage (a 50% to 60% carriage rate in hemodialysis
    patients).
12. Nasal carriage may result in seeding the skin with autogenous S
    aureus, leading to catheter site infection, tunnel track infection,
    or bacteremia.
13. Catheter placement near the patient's nose and mouth, such as
    occurs with subclavian or jugular vein catheters, exposes the
    patient's catheter exit site to nasal drainage/discharge and
    infectious airborne droplets.
    13.1 Methicillin-resistant S aureus may be transmitted in this
           mode.
    13.2 A surgical mask worn by the patient and nurse any time
           the catheter is accessed reduces the spread of infectious
           droplets and reduces contamination of the catheter site.




                                  31
G. Local infection of a dialysis AV graft should be treated with
   appropriate antibiotics based on culture results and by
   incision/resection of the infected portion of the graft.
   1. Extensive infection of a dialysis AV graft should be treated with
       antibiotics and total resection of the graft.
   2. Infection of a newly placed graft (ie, within 1 month) should be
       treated with antibiotics and by removing the graft, regardless of
       the extent of the infection.
   3. Initial antibiotic treatment should cover both Gram-negative and
       Gram-positive organisms and should cover Enterococcus
       species.
H. Infections of primary AV fistulae are rare and should be treated as
   subacute bacterial endocarditis with 6 weeks of antibiotic therapy.
   Though septic emboli are rare, they call for taking the fistula down.
I. Tunneled cuffed catheter infection is a serious problem.
   Appropriate treatment is dependent upon the nature of the infection:
J. Catheter exit site infections characterized by redness, crusting, and
   exudate at the exit site in the absence of systemic symptoms and
   negative blood cultures should be treated as follows:
K. Apply topical antibiotics, ensuring proper local exit site care; do not
   remove the catheter.
L. If there is tunnel drainage, parenteral antibiotics (anti-
   staphylococcal, anti-streptococcal therapy should be initiated
   pending exit site cultures) in addition to following appropriate local
   measures. Definitive therapy should be based on culture results.
   The catheter should not be removed unless the infection fails to
   respond to therapy.
M. If the infection fails to respond to therapy, the catheter should be
   removed and replaced by using a different tunnel and exit site.
N. Catheter-related bacteremia, with or without systemic signs or
   symptoms of illness, should be treated by initiating parenteral
   treatment with an antibiotic(s) appropriate for the organism(s)
   suspected, usually Staphylococcus and Streptococcus.
O. Definitive therapy should be based on the organism(s) isolated. The
   catheter should be removed in all instances if the patient remains
   symptomatic more than 36 hours. The catheter should also be
   removed in any clinically unstable patient.




                                 32
P. Antibiotic bloc (filling antibiotic in the catheter lumen) after
   dialysis session should be applied to control the systemic infection.
Q. A new permanent access should not be placed until blood cultures,
   performed after cessation of antibiotic treatment, have been
   negative for at least 48 hours.

4. Management of Complications: Stenosis, Thrombosis, and
Aneurysm
A. All patients, particularly those in high-risk groups, should be
   monitored for the development of limb ischemia following AV
   access construction.
B. Patients in high-risk groups (diabetic, elderly, those with multiple
   access attempts in an extremity) should be monitored closely for the
   first 24 hours postoperatively. Monitoring should include:
   1. Subjective assessment of complaints, including sensations of
       coldness, numbness, tingling, and impairment of motor function
       (not limited by postoperative pain).
   2. Objective assessment of skin temperature and gross sensation,
       and movement in addition to distal arterial pulses in comparison
       to the contralateral side.
   3. Teaching patients to immediately report any coldness, loss of
       motion, or significant reduction in sensation.
   4. Patients with an established fistula should be assessed monthly.
       The following are recommended as part of this assessment.
       4.1 Obtaining an interval history of increased distal coldness or
             distal pain during dialysis, decreased sensation, weakness
             or other reduction in function, or skin changes.
       4.2 Confirming any abnormalities by physical examination.
C. Appropriate intervention in AV grafts should be initiated upon
   identification of:
   1. Hemodynamically significant stenosis.
   2. Infection. An infected graft should be treated surgically.
   3. Graft degeneration and pseudoaneurysm formation. Grafts
       should be surgically revised when:
       3.1 Severe degenerative changes of the graft or overlying skin
           are present.
       3.2 Skin above the graft is compromised.




                                   33
         3.3 There is a risk of graft rupture due to poor eschar formation
             or there is evidence of spontaneous bleeding.
         3.4 Limited puncture sites are available due to the presence of a
             large or multiple pseudoaneurysm(s).
D.   Appropriate intervention in primary AV fistulae should be initiated
     upon identification of:
     1. Inadequate flow to support the prescribed dialysis blood flow.
     2. Hemodynamically significant venous stenosis.
     3. Aneurysm formation. A primary AV fistula should be revised
         when an aneurysm develops if:
         3.1 The skin overlying the fistula is compromised.
         3.2 There is a risk of fistula rupture.
         3.3 Available puncture sites are limited.
E.   Stenoses that occur in a dialysis AV graft or primary AV fistula
     (venous outflow or arterial inflow) should be treated with
     percutaneous transluminal angioplasty or surgical revision if the
     stenosis is >50% of the lumen diameter and is associated with the
     following abnormalities:
     1. Previous thrombosis in the access.
     2. Elevated venous dialysis pressure.
     3. Abnormal urea or other recirculation measurements.
     4. Abnormal physical findings.
     5. Unexplained decrease in measure-ment of dialysis dose.
     6. Decreasing access flow.
F.   Each dialysis center should determine which procedure (angioplasty
     versus surgical revision) is best for the patient based on the
     expertise at that center.
G.   Stenosis, as well as the clinical parameters used to detect it, should
     return to within acceptable limits following intervention.
H.   Centers should monitor stenosis treatment outcomes on the basis of
     patency; reasonable patency goals (for the center as a whole) for
     PTA and surgical revision in the absence of thrombosis are:
I.   PTA: 50% unassisted patency at 6 months; no more than 30%
     residual stenosis post procedure, and resolution of physical
     indicators of stenosis.
     1. Surgical revision: 50% unassisted patency at one year.
J.   If angioplasty is required more than 2 times within 3 months, the




                                    34
   patient should be referred for surgical revision if such an option is
   available and if the patient is a good surgical candidate.
K. Stents are useful in selected instances (eg, limited residual access
   sites, surgically inaccessible lesions, contraindication to surgery or
   when PTA fails.
L. Percutaneous intervention with transluminal angioplasty is the
   preferred treatment for central vein stenosis.
M. Stent placement combined with angioplasty is indicated in elastic
   central vein stenoses or if a stenosis recurs within a 3-month period.
N. Thrombosis of an AV graft should be corrected with surgical
   thrombectomy or with pharmacomechanical or mechanical
   thrombolysis. The choice of technique to treat thrombosis should be
   based on the expertise of the center. However, it is essential that:
   1. Treatment is performed rapidly following detection of
       thrombosis to minimize the need for temporary access.
   2. The access is evaluated by Dopoler ultrasound.
   3. Residual stenosis is corrected by angioplasty or surgical
       correction.
   4. The procedure is performed as outpatient procedure under local
       anesthesia. Access revision may require up to a 24-hour obser-
       vation to evaluate swelling and steal.
   5. Monitoring tests used to screen for venous obstruction should
       return to normal following intervention.
O. Thrombosis of an AV fistula is difficult to treat. Neither
   percutaneous nor surgical techniques offer good results. Each
   institution should attempt to resolve thrombosis with the technique
   that is preferred at that institution.
P. Catheter dysfunction is defined as failure to attain and maintain an
   extracorporeal blood flow sufficient to perform hemodialysis
   without significantly lengthening the hemodialysis treatment.
   Sufficient extracorporeal blood flow is around 300 mL/min.
R. Tissue plasminogen activator (TPA) and recombinant urokinase
   (rUK) may be used to treat thromboed catheters. If they fail, the
   thrombosed catheter should be changed over a guidewire.
S. Intra-catheter urokinase infusion (eg, 20.000 units/lumen/hour) for
   6 hours if a fibrin sheath is present or a luminal thrombosis remains.
T. Better approach is to use TPA 2mg/2ml to fill the catheter.The




                                35
   dwell time is 2 hours. Successful recanalization should be if blood
   flow is more than 200 ml/min. The dose can be repeated if needed.
U. Needle insertion into the area of pseudoaneurysm should be
   avoided. Pseudoaneurysm of a dialysis AV graft should be treated
   by resection and insertion of an interposition graft if the
   pseudoaneurysm:
   1. Is characterized by rapid expansion in size.
   2. Exceeds twice the diameter of the graft.
   3. Threatens viability of the overlying skin.
   4. Is infected.
V. Aneurysms of primary AV fistulae require surgical intervention
   only when the aneurysm involves the arterial anastomosis.
   Venipuncture should avoid the aneurysm.
W. Dialysis centers should:
   1. Institute monitoring programs to detect vascular accesses at risk.
   2. Establish quality assurance programs that track access
      complication rates and outcomes.
   3. Develop methods that extend access use-life by:
      3.1 Increasing the percentage of patients with native or primary
          AV fistulae.
      3.2 Early identification and referral of patients with progressive
          kidney disease to nephrologists, allowing access construction
          well in advance of the need for hemodialysis.
      3.3 Reevaluation for a native AV fistula after every access
          failure.
      3.4 Periodic monitoring of accesses to detect hemodynamically
          significant stenoses prior to thrombosis.
      3.5 Expeditious referral of patients for appropriate angioplasty or
          surgical revision following the detection of stenoses.
      3.6 Implementing staff and patient education programs on the
          importance and care of vascular access.
      3.7 Primary AV fistulae should be constructed in at least 50% of
          all new kidney failure patients electing to receive
          hemodialysis as their initial form of renal replacement
          therapy. Ultimately, 40% of prevalent patients should have a
          native AV fistula.
      3.8 Patients should be re-evaluated for possible construction of a




                                  36
        primary AV fistula after failure of every dialysis AV access.
    3.9 Each center should establish a database to track the types of
        accesses created and the complication rates.
4. Less than 10% of chronic maintenance hemodialysis patients
    should be maintained on catheters as their permanent chronic
    dialysis access. In this context, chronic catheter access is defined
    as the use of a dialysis catheter for more than 3 months in the
    absence of a maturing permanent access.
5. ESRD patients should be educated on the risks and benefits
    associated with catheters and strongly encouraged to allow the
    creation of an AV fistula for permanent access where
    appropriate.
6. The rate of graft thrombosis should not exceed 0.5 thrombotic
    episodes per patient year at risk.
7. After adjusting for initial failures (ie, failures within the first 2
    months of fistula use), the rate of thrombosis of native AV
    fistulae should be less than 0.25 episodes per patient year at risk.
8. Dialysis centers should examine their thrombosis rates and the
    underlying causes as part of an ongoing quality care program.
9. The rate of infection should not exceed 1 % in primary AV
    fistulae and should not exceed 10% in dialysis AV grafts, both
    calculated over the use-life of the access.
10. For tunneled cuffed catheters, the recommended target rate of
    systemic infection is less than 10% at 3 months and less than
    50% at 1 year.
11. The primary access failure rates of virgin dialysis AV grafts in
    the following locations and configurations should not be more
    than:
    11.1 Forearm straight grafts:15%
    11.2 loop grafts: 10%
    11.3 Upper arm grafts: 5%
12. The creation and maintenance of access sites as distally as
    possible is encouraged to preserve more proximal veins for
    future access options.
13. Each center should monitor its performance to identify problems
    in access construction and use.
14. The primary failure rate of tunneled cuffed catheters should be




                              37
    no more than 5%. The cumulative incidence of the following
    insertion complications should not exceed 2% of all catheter
    placements:
    14.1 Pneumothorax requiring a chest tube.
    14.2 Symptomatic air embolism.
    14.3 Hemothorax.
    14.4 Hemomediastinum.
    14.5 Hematoma requiring evacuation.
15. The cumulative patency rate of dialysis AV grafts ( the number
    of grafts that remain patent regardless of the number of primary
    interventions and/or thrombectomies during the given time
    period) should be at least 70% at 1 year, 60% at 2 years, and
    50% at 3 years.




                              38
                V. Adequacy of Hemodialysis
    1. Regular Measurement of the Delivered Dose of
        Hemodialysis

A. The dialysis care team should routinely measure and monitor the
   delivered dose of hemodialysis.
B. All patients receiving hemodialysis in the same dialysis facility
   should have the delivered dose of hemodialysis measured using the
   same method.
C. The delivered dose of hemodialysis in adult and pediatric patients
   should be measured using formal urea kinetic modeling, employing
   the single-pool, variable volume model.
D. The measurement of the delivered dose of hemodialysis includes:
   1. The availability of dialysis unit staff to properly collect blood
      samples and record information from the dialysis session, such
      as the type of dialyzer used, intradialytic weight loss, blood and
      dialysate flows, true dialysis time, etc; and the time to record,
      enters, and processes this information.
   2. Urea is the substance that is most often monitored in clinical
      practice as a surrogate for measurement of the clearance of small
      solutes in general.
   3. The dialysate collection method is an alternative approach for
      quantifying the delivered hemodialysis dose. This method has
      been considered to be the gold standard for urea kinetic analysis,
      but not routinely available, and impractical to implement in most
      hemodialysis units.
   4. To normalize for differences in the size and habitus of patients, a
      dose of hemodialysis (prescribed or delivered) is best described
      as the fractional clearance of urea as a function of its distribution
      volume (Kt/V). The fractional clearance is operationally defined
      as the product of K (dialyzer clearance measured in liters per
      minute [L/min]), the t (treatment time) and V (volume of
      distribution of urea measured in L).
   5. Kt/V may be determined by formal urea kinetic modeling
      (UKM) or by extrapolation from the fractional change in blood
      urea concentration (URR) during a dialysis session.




                                    39
6. URR = 100 X (1 - Ct/Co) in which Ct is the postdialysis BUN
    and Co is the predialysis BUN.
7. Formal urea kinetic modeling (UKM) is the most rigorous
    method for prescribing dialysis treatment and evaluating the
    consistency with which the prescribed treatment is delivered to
    the patient. UKM requires accurate measurement of:
    7.1. Predialysis and postdialysis BUN for the first dialysis
           treatment of the week and the predialysis BUN for the
           second dialysis session of the week in a thrice-weekly
           hemodialysis schedule.
    7.2. Predialysis and postdialysis weights at the time of the first
           hemodialysis treatment of the week.
    7.3. The actual treatment time (the exact number of minutes
           during which the hemodialysis treatment was delivered on
           the first dialysis treatment of the week).
    7.4. The effective clearance of the dialyzer as measured in the
           hemodialysis unit (not the in vitro clearance value
           reported by the manufacturer alone).
8. Formal UKM provides a mechanism to check for errors in the
    delivered dose of hemodialysis.
9. A discrepancy between the kinetically derived V and the V
    expected from anthropometric calculations is an indicator of
    potential technical problems with the hemodialysis session. such
    as:
    9.1. Blood flow from the vascular access.
    9.2. The performance of the dialyzer.
    9.3. The dialysate flow during the hemodialysis treatment.
    9.4. The dialysis machine programming.
    9.5. The hemodialysis treatment time.
    9.6. The predialysis BUN sampling.
10. The disadvantages of formal UKM are logistical:
    10.1. The complexity of the calculations requires the use of
           computational devices and software.
    10.2. Physical parameters, such as the K and V, are difficult to
           measure and to monitor,
    10.3. The actual treatment time can be difficult to determine.
    10.4. The time required for the dialysis unit staff to accurately




                                40
             collect and adequately process all patient information to
             support these calculations can be significant in large
             dialysis units.
   11. KT/V derived from URR needs to be adjusted to the level of
      ultrafiltration. URR does not measure the residual renal
      function. However, it is the most practical method at bed side.
E. Double pool Model
   1. During the course of a hemodialysis session, flow-volume
      disequilibrium for urea between vascular beds results in the
      preferential loss of urea from the well-perfused, but relatively
      urea-depleted vascular beds. This compartmentalization of urea
      results in rebound in the BUN concentration over the 15-60
      minutes after the completion of hemodialysis.
   2. The double-pool, variable-volume urea kinetic model may more
      accurately quantify intradialytic urea removal and may result in
      a more precise normalized protein catabolic rate (NPCR)
      because of the more accurate assessment of V (in comparison to
      an anthropometric value)
   3. The need to obtain the postdialysis BUN sample 30 to 60
      minutes after the completion of hemodialysis (equilibrated
      postdialysis BUN sample) can be overcome by the following
      formula depending upon the location of the vascular access and
      the site from which the postdialysis BUN sample was obtained.
      Kt/Vsp. calculated using an arterial postdialysis BUN sample
      from an arteriovenous vascular access (art Kt/V), will be greater
      than that calculated from a mixed venous postdialysis BUN,
      drawn through a venovenous vascular access (ven Kt/V).
      3.1. The corresponding equilibrated eKt/V values are
             calculated by:
             Arterial Kt/V equilibrated = art Kt/Vsp- (0.6 X art
             Kt/Vsp/T) + 0.03
             Venous Kt/V equilibrated = ven Kt/Vsp - (0.47 X ven
             Kt/Vsp/T) + 0.02 in which T is the dialysis treatment time
             in hours , t is the dialysis time in minutes and sp is single
             pool .
      3.2. This approach is based on the observation that the 30-
             minute postdialysis BUN concentration is not statistically




                                    41
             different from the intradialytic concentration 30 minutes
             before the end of hemodialysis.
      3.3.   Using the formula for calculating Kt/Vequil, the impact of
             the duration of hemodialysis on the single-pool is
             included.
      3.4.   The use of Kt/Vequil is considerably easy to reflect the
             two-compartment urea kinetic model and calculate the
             delivered dose of hemodialysis. It is a useful adjunct to a
             complete kinetic modeling program.

  2. Dialysis Dose

A. The dialysis care team should deliver a Kt/V of at least 1.2 (single-
   pool, variable volume) for both adult and pediatric hemdialysis
   patients. For those using the URR, the delivered dose should be
   equivalent to a Kt/V of 1.2, ie, an average URR of 65%. However,
   URR can vary substantially as a function of fluid removal.
B. To prevent the delivered dose of hemodialysis from falling below
   the recommended minimum dose, the prescribed dose of
   hemodialysis should be Kt/V 1.3. In terms of URR, a Kt/V of 1.3
   corresponds to an average URR of 70%, but the URR
   corresponding to a Kt/V of 1.3 can vary substantially as a function
   of ultrafiltration.
C. The delivered dose of hemodialysis should be measured at least
   once a month in all adult and pediatric hemodialysis patients. The
   frequency of measurement of the delivered dose of hemodialysis
   should be increased when:
   1. Patients are noncompliant with their hemodialysis prescriptions
      (missed treatments, late for treatments, early sign-off from
      hemodialysis treatments, etc.).
   2. Frequent problems are noted in delivery of the prescribed dose
      of hemodialysis (such as variably poor blood flows, or treatment
      interruptions because of hypotension or angina pectoris).
   3. Wide variability in urea kinetic modeling results is observed in
      the absence of prescription changes.
   4. The hemodialysis prescription is modified.




                                 42
3. Urea Sampling

A. Predialysis and postdialysis blood samples for measurement of
     BUN levels must be drawn at the same hemodialysis session.
B. Blood samples for BUN measurement must be drawn in a particular
     manner. Predialysis BUN samples should be drawn immediately
     prior to dialysis, using a technique that avoids dilution of the blood
     sample with saline or heparin.
C.   Postdialysis BUN samples should be drawn using the slow
     flow/stop pump technique that prevents sample dilution with
     recirculated blood and minimizes the confounding effects of urea
     rebound.
D.   Slow flow sampling technique:
     1. With the blood pump still running at 50 to 100 mL/min, draw
        the blood sample for postdialysis BUN measurement from the
        arterial sampling port closest to the patient. Drawing the blood
        from the arterial sampling port ensures the postdialysis BUN
        measurement is performed on undialyzed blood.
     2. Stop the blood pump and complete the patient disconnection
        procedure as per dialysis unit protocol.
E.   Stop pump sampling technique.
     1. Immediately stop the blood pump.
     2. Clamp the arterial and venous blood lines. Clamp the arterial
        needle tubing.
     3. Blood for postdialysis BUN measurement may be sampled by
        needle aspiration from the arterial sampling port closest to the
        patient. Alternatively, blood may be obtained from the arterial
        needle tubing after disconnection from the arterial blood line and
        attaching a vacutainer or syringe without a needle.
     4. Blood is returned to the patient and the patient disconnection
        procedure proceeds as per unit protocol.
F.   Hemodialysis facilities should adopt a single BUN sampling
     method. If several different methods are used, the sampling method
     should be routinely recorded.
G.   The sampling method used for a given patient should remain
     consistent. The predialysis and postdialysis BUN samples for a




                                    43
   given patient should be processed in the same batch analysis at the
   laboratory.

4. Adequate dosing

A. If the delivered Kt/V falls below 1.2 or the URR declines to <65%,
   on a single determination, at least one of the following actions
   should be performed:
   1. Investigate potential errors in the delivery of the prescribed
       hemodialysis dose such as:
       a. Clearance (K) less than assumed effective hemodialysis
          treatment.
       b. Time (Td) less than prescribed.
       c. Errors in blood sampling or processing for BUN
          concentration.
   2. Empirically increase the prescribed dose of hemodialysis.
   3. The impact of these corrective interventions should be followed
       by performing more frequent measurements of Kt/V or URR.

  5. Frequency of dialysis


A. The standard HD dose should be delivered as 4 hours. Even if the
   standards of adequacy such as dose expressed as eKt/V are reached,
   a minimum time of 12 h/week is desirable.
B. Treatment time and/or frequency should be increased in patients
   with hemodynamic instability or cardiovascular problems. The
   same may apply for the aged HD patients, who suffer more
   frequently from the above-mentioned conditions.
C. Long, slow, daily nocturnal HD: is performed 6-7 nights per week
   for 8-10 h during sleep at home. This may result in better control of
   blood pressure with reduced use of antihypertensive drugs, reduced
   incidence of intradialytic hypotension and cardiovascular
   complications. In addition there is increased weekly clearance of
   middle     molecules     and    phosphate,    with     control     of
   hyperphosphatemia without any phosphate binders.
D. Short/standard daily HD: Prolonged experience in a single unit with




                                 44
   daily HD sessions of 2-2.5 h and 'standard efficiency' may have
   better control of hypertension and intradialytic fluid removal,
   improved nutritional status (increase in serum albumin, and dry
   weight), with substantial benefits in terms of well being. There is
   increased small- and middle-MW solute clearances and lower peak
   concentration of uremic toxins.
E. Dialysis duration up to 5.5 h is independently associated with
   survival even after adjustment of the relative risk of death by the
   dose of HD, either in terms of Kt/Vsp or eKt/V.
F. The more frequently intermittent HD is performed, the more it
   approaches continuous therapy.

  6. Maximizing Patient Adherence to the Hemodialysis
     Prescription

A. Without compromising the delivered dose of hemodialysis, efforts
   should be undertaken to modify the hemodialysis prescription to
   prevent the occurrence of intradialytic symptoms that adversely
   affect patient comfort and adherence. These efforts may include one
   or more of the following:
   1. Avoid excessive ultrafiltration.
   2. Slow the ultrafiltration rate.
   3. Perform isolated ultrafiltration.
   4. Increase the dialysate sodium concentration.
   5. Switch from acetate to bicarbonate-buffered dialysate.
   6. Reduce the dialysate temperature.
   7. Administer midodrine predialysis.
   8. Correction of anemia to the range recommended by Saudi
      anemia guidelines.
   9. Administer supplemental oxygen.




                                  45
         VI. Common Infections in HD Patients
 1.   Tuberculosis

A. Tuberculin skin test (purified protein derivative of tuberculin; PPD)
   should be performed in all high-risk patients such as
   immunosuppressed and malnourished patients.
B. TB should not be excluded by a negative PPD.
C. All the dialysis patients with unexplained fever, weight loss,
   anorexia, hepatomegaly, unexplained pulmonary infiltrates, pleural
   effusion, ascites, or lymph- adenopathy should be vigorously
   evaluated for an active focus of TB.
D. Prophylaxis of TB in HD patients with a positive PPD is
   recommended.
E. In patients with a negative PPD test, preventive therapy should be
   considered if they have been exposed to a patient with clinically
   active TB.
F. The principles of treatment of TB in the general population apply to
   dialysis patients but there are no controlled studies with regard to
   the optimum treatment regimen in HD patients. Modifications of
   dose are required for most antitubercular drugs in HD.

 2.   Viral Infection

A. Screening for hepatitis B virus (HBV) markers should be performed
   in all patients starting HD or transferring from another unit whether
   they received anti HBV vaccination or not.
B. Screening should be repeated every 3-6 months once on HD,
   depending on the prevalence of HBV infection in the unit.
   Screening for hepatitis C virus (HCV) antibodies should be
   performed in all patients starting HD or transferring from another
   unit.
C. Screening for HCV should be repeated at least every 6 months once
   on HD.
D. HCV screening should include an ELISA assay and a confirmatory
   testing with a more specific assay (RIBA).




                                 46
E. Screening for HIV infection should be done in all patients starting
   HD or transferring from another unit. Once on routine HD, repeat
   of screening is not recommended.
F. Universal precautions for prevention of transmission of blood-borne
   pathogens in the health care setting should be rigorously respected
   in all HD units. These include:
   1. Cleaning and disinfection of instruments, machines and
       environmental surfaces after each treatment.
   2. Appropriate disposal of linens,sheets and used disposables.
   3. Avoidance of sharing articles among patients.
   4. Frequent hand washing and use of disposable gloves.
   5. Use of protective eye wear and face mask.
G. Dialyzed HBsAg-positive patients should be treated in separate
   rooms with dedicated machines.
H. In addition to universal precautions, which are the most efficacious
   preventive measures, treatment of anti- HCV patients in separate
   areas with dedicated staff is recommended in units with a high
   prevalence of HCV infection..
I. Passive immunization or passive-active immunization against HBV
   should be applied for post-exposure protection after accidental
   inoculation in staff as preventive treatment in both health care
   workers and dialysis patients when unresponsive to vaccination.
J. A combination of AZT, lamivudine, and a protease inhibitor
   should be recommended for HD staff members accidentally
   exposed to HIV.
K. Active immunization against HBV should be undertaken in all HD
   staff members.
L. Either a 0-, 1-, 6-month or a 0-, 1-, 2- and 12-month vaccination
   schedule should be used.
M. Monitoring of acquired antibody titre is advisable in these subjects.
   Additional doses should be administered to staff members who do
   not develop protective antibody titres (threshold level 10 mIU/ml).
N. Patients with progressive chronic renal failure should be vaccinated
   against HBV preferably before they start onHD.
O. HD patients who have not been previously immunized against HBV
   should be vaccinated.
P. Anti-HBs testing is recommended 1-2 months after the primary




                                47
   series has been completed and 6-12 months thereafter, depending
   on the local incidence of HBV infection. Additional doses should
   be administered to patients who do not develop protective antibody
   titres (threshold level 10 mIU/ml). Subsequent routine testing is
   recommended every 6 months. A booster dose is recommended if
   the anti-HBs titre is less than 10 mIU/ml.
Q. To inhibit HBV replication, alpha interferon (IFNa) and/or
   lamivudine should be administered to transplant candidates who
   have biopsy-proven HBV-chronic liver disease.
R. IFNa should be considered for HD patients with biopsy-proven
   chronic hepatitis due to HCV awaiting renal transplantation.

3. Vaccinations

A. Pneumococcal polysaccharide vac-cine is recommended especially
   in the elderly HD patients. Revaccination is also recommended 5
   years after the previous dose.
B. Influenza vaccine is recommended annually before the beginning of
   the influenza season for HD patients.
C. Patient on dialysis should receive the diphtheria and tetanus toxoids
   as recommended for healthy persons.




                                   48
 VII. Cardiovascular Risk Factors in Hemodialysis
                     patients
A. Patients' cardiovascular risk should be formally assessed and
   documented at the onset of haemodialysis and 6 monthly thereafter.
   Risk assessment includes modifiable risk factors such as cigarette
   smoking, hyperglycemia, dyslipidemia, and hypertension.
B. All patients should have total cholesterol, triglycerides, and HDL
   cholesterol measured at presentation, and 3 months after beginning
   of hemodialysis.
C. LDL cholesterol should be calculated by the Friedewald formula
   (LDL         cholesterol=      total        cholesterol-       (HDL
   cholesterol+triglyceride/5) when triglycerides are 400 mg/dl (4.56
   mmol/L). For triglycerides between 400 and 800 mg/dl (4.56-9.12
   mmol/L) direct LDL measurements should be done.
D. All blood collections for lipid screening should be performed,
   whenever possible, on patients in the fasting state. When screening
   for dyslipidaemia is done, blood should be drawn immediately
   before or at least 12 h after a regularly scheduled hemodialysis
   treatment.
E. Patients should have a complete lipid profile measured every 6
   weeks during the initiation phase of lipid lowering intervention.
   When target levels have been met the frequency can be reduced to
   every 4-6 months.
F. Any patient with elevated LDL cholesterol or other forms of
   dyslipidaemia (elevated total cholesterol and triglycerides and/or
   low HDL cholesterol) should undergo clinical or laboratory
   assessment to rule out other secondary causes such as glucose
   intolerance, hypothyroidism, obstructive liver disease, alcohol
   abuse, or drugs that decrease HDL cholesterol..
G. Screening for dyslipidemia should not be performed after surgery
   or during conditions, which may acutely affect the lipid profile.
H. Patients without any comorbid conditions and a low total
   cholesterol (<150 mg/dl; 3.9 mmol/L) should be investigated for
   possible nutritional deficits.
I. Patients with elevated LDL cholesterol (100-129 mg/dl; 2.6-3.4
   mmol/L) should be treated to achieve LDL cholesterol <100 mg/dl,




                                49
J. Treatment beyond LDL cholesterol lowering should be initiated in
   patients with triglycerides > 180 mg/dl (2.0 mmol/L). In patients
   with LDL cholesterol 100-129 mg/dl (2.6-3.4 mmol/L) or
   triglycerides > 180 mg/dl         (2.0 mmolul) therapeutic lifestyle
   changes should be initiated, whenever possible.
K. Patients with dyslipidaemia should have dietary interviews and/or
   diaries focusing on the type and amount of fat. Dietary interviews
   should be repeated in yearly intervals when target lipid levels are
   not met during concomitant drug therapy.
L. If after 3 months of therapeutic lifestyle changes, LDL cholesterol
   is > 100 mg/dl (2.6 mmol/Ll) treatment with a HMG-CoA reductase
   inhibitor should be initiated.
M. If LDL cholesterol goal is not achieved after 6 weeks of treatment
   the dose of the HMG-CoA reductase inhibitor should stepwise be
   increased and a lipid profile be repeated after another 6 weeks.
N. If LDL cholesterol goal is not achieved with therapeutic lifestyle
   changes and optimal treatment with a HMG-CoA reductase
   inhibitor additional measures should be considered.
O. Patients with triglycerides between 180-499 mg/dl (2.0-5.7
   mmol/L, after 3 months of therapeutic lifestyle changes, should be
   treated with a HMG-CoA reductase inhibitor, to achieve a non-
   HDL cholesterol < 130 mg/dl.
P. Patients with very high triglycerides >500 mg/dl (6 mmol/l) should
   be treated with a fibric acid analogue with the dose adjusted
   according to renal function.
Q. In patients with triglycerides > 800 mg/dl (9 mmol/L), resistant to
   any intervention, the administration of fish oil and/or a switch to
   low-molecular weight (LMW) heparin as anticoagulant during
   hemodialysis therapy should be considered.
R. Combining a fibric acid analogue with a HMG-CoA reductase
   inhibitor should be avoided due to the high risk of rhabdomyolysis.
S. Serum calcium and phosphate should be measured in routine
   intervals and obtained immediately before the hemodialysis session
   starts.
T. When serum phosphate is elevated you may consider recirculation
   and investigate effective duration of dialysis treatment.
U. The target range of serum phosphorus in dialysis patients should be




                                 50
   0.8-1.8 mmol/L (2.5-5.5 mg/dl) aiming for a normal Ca x P ion
   product (55 mg2dl2)
V. Serum calcium and phosphate should be measured in routine
   intervals and obtained immediately before the hemodialysis session
   starts.
W. Lp(a) should be measured in patients with a long life expectancy on
   renal replacement therapy in 6-month intervals in order to quantify
   risk for subsequent cardiovascular disease.
X. In young patients with a long life expectancy on renal replacement
   therapy and an Lp (a) 30 mg/dl, the apo (a) isoform should be
   determined.
Y. Determination of plasma fibrinogen, as a marker of myocardial
   damage and activated acute-phase response, is recommended at 6-
   month intervals to appropriately assess cardio-vascular disease risk.
Z. Smokers with plasma fibrinogen >3 g/dl should vigorously be
   encouraged to stop smoking in order to decrease plasma fibrinogen.
AA. Folate therapy can be administered in order to lower total plasma
     homo-cysteine. Folate therapy should always be combined with
     vitamins B6 and B12.
BB. C-reactive protein (CRP) testing should be included in the
     routine laboratory evaluation for risk evaluation and stratification
     in stable patients. Measurements should be done at least in 3
     monthly intervals.
CC. Patients with CRP > 8 mgul should be screened for silent
     infection of hemodialysis access grafts, para- dontitis or any low-
     grade infection.
DD. In patients with elevated CRP > 8 mg/dl) biocompatibility of
     dialyzer membrane and hemodialysis fluid quality should be
     checked.




                                   51
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256. Al Shohaib S. Tuberculous peritonitis in hemodialysis patients with chronic liver
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259. AL-Homrany M A, Bilal A M.Psycho-social fatures of chronic dialysis pients in
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260. Al Dayel AG, Al Oraifi I, Ezzibdeh M Y, Egail S A, El Sayed Essam, Abou
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264. Saxena AK, Panhotra BR, Naguib M, Uzzaman W, Al MK. Nosocomial
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265. Saxena AK, Panhotra BR, Naguib M, Sundaram DS, Venkateshappa CK,
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266. Ayoola EA, Want MA, Gadour MO, Al-Hazmi MH, Hamza MK. Hepatitis E
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267. Saeed Abdulrahman I, Al-Mueilo SH, Bokhary HA, Ladipo GO, Al-Rubaish
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268. Dahduli SA, Qattan NM, Al-Kuhaymi RA, Al-Jabreen MA, Al-Khader AA.
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269. Bhat A, Solangi S, Osman M. Nosocomial infective endocarditis in
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278. Saxena AK, Panhotra BR. The vulnerability of middle-aged and elderly patients
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279. Saxena AK, Panhotra BR. The impact of nurse understaffing on the transmission
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280. Saxena AK, Panhotra BR, Chopra R. Advancing age and the risk of nasal
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283. Sobki SH, Al-Etah H , El Gezeery A, Al Khader A. effect of age on pituitary
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284. Shaheen FA, Kurpad R, Al-Attar BA, Muna B, Al-Khader AA. Comparative
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287. Badawi L, Akeel N, Shaheen F AM, Al Ahmadi S. Dose and lipid lowering
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                          Disclaimer
  These Guidelines are based upon the best information available at
the time of publication. They are designed to provide information
and assist decision-making. They are not intended to define a
standard of care, and should not be construed as one. Neither should
they be interpreted as prescribing an exclusive course of
management.
 Variations in practice will inevitably and appropriately occur
when clinicians take into account the needs of individual patients,
available resources, and limitations unique to an institution or type
of practice. Every health-care professional making use of these
Guidelines is responsible for evaluating the appropriateness of
applying them in the setting of any particular clinical situation.




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