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2005-4144s1_06_Ruiz-Nocturnal Home Hemodialysis

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					Nocturnal Home Hemodialysis
                  Draft

   Claudia C. Ruiz-Zacharek, M.D.
      Medical Officer / Nephrologist

        Gastroenterology and Renal
              Devices Branch
Overview

 1. Background Information
 2. Nocturnal Home Hemodialysis
 3. Clinical Studies
Background Information

   Conventional Hemodialysis
        typically in-center, 4 hours 3 X week

        Patient has a passive role during treatment


   Nocturnal Home Hemodialysis
        performed at home, typically at night, and while the
         patient sleeps.

        Patient is the performer of the treatment
Data from the United States Renal
Data System (USRDS)

   Prevalence of patients on hemodialysis in
    the United States, 2002: 281,594

   0.3% (843) home hemodialysis patients

   115 NHD patients in 13 centers in North
    America*

    * Lockridge, et. al., Adv Ren Replace Ther 2001; 8(4):250-256.
Definitions and Nomenclature

 Nocturnal Hemodialysis (NHD)
     NightlyHemodialysis
     Nocturnal Home Hemodialysis


   In-center nocturnal hemodialysis,
   Long nocturnal hemodialysis
   Slow nocturnal hemodialysis, and
   Daily hemodialysis.
Definitions and Nomenclature (cont’d)

 Nocturnal Home Hemodialysis

  Performed at home
  Absence of medical personnel
  Frequency has reportedly ranged from
    5-7 nights a week
  Length is 6-10 hours per night
Definitions and Nomenclature (cont’d)

 Nocturnal Home Hemodialysis

  Blood flows (QB) 200-300 ml/min,
  Dialysate flows (QD) usually ~300
      ml/min, up to 800 ml/min*


 * Pierratos, A. Nephrol Dial Transplant 1999; 14:2835-2840
Definitions and Nomenclature (cont’d)


  Human factors
  Physician labeling
  Patient labeling
  Training
Definitions and Nomenclature (cont’d)

Human Factors

     the objective is to improve human
      performance

     reduce the burden on training and labeling

     reduce the likelihood of use error and
      patient injury
Definitions and Nomenclature (cont’d)

Human Factors

   The objective is to improve human
    performance

   Reduce the burden on training and
    labeling

   Reduce the likelihood of use error and
    patient injury
Definitions and Nomenclature (cont’d)

Physician’s Instructions for Use

 The manual that accompanies a medical
 device

     indications for use statement,
     contraindications,
     precautions and warnings.
Definitions and Nomenclature (cont’d)

Physician’s Instructions for Use
 The manual that accompanies a medical
  device
     indications for use statement,
     contraindications,
     precautions and warnings.
 It should also include relevant data from
 clinical studies and instructions for
 using and caring for the device.
Definitions and Nomenclature (cont’d)

Patient Instructions for Use

 The manual that accompanies a medical
 device
     indications for use statement,
     contraindications,
     precautions and warnings.
Definitions and Nomenclature (cont’d)
Patient Instructions for Use
 The manual that accompanies a medical
  device
     indications for use statement,
     contraindications,
     precautions and warnings.
 It should also include relevant data from
 clinical studies and instructions for using and
 caring for the device.
Definitions and Nomenclature (cont’d)

Patient Instructions for Use

   The manual that accompanies a medical device
       indications for use statement,
       contraindications,
       precautions and warnings.
   It should also include relevant data from
    clinical studies and instructions for using and
    caring for the device.
   Written for a person with no medical training.
Definitions and Nomenclature (cont’d)

 Training

  Teaching provided by the manufacturer
  Medical expert to train the lay user
  Lay user to successfully use the device
Overview

 1. Background Information
 2. Nocturnal Home Hemodialysis
 3. Clinical Studies
Overview

 1. Background Information
 2. Nocturnal Home Hemodialysis
 3. Clinical Studies
Nocturnal Home Hemodialysis

   Device design and Components
   Human Factors Issues
   Water Quality
   Use of a Partner and Remote Monitoring
   Vascular Access and Extracorporeal Circuit
    Connections
   Labeling
   Lay-user Training
Nocturnal Home Hemodialysis

   Conventional                Nocturnal Home
    Hemodialysis                 Hemodialysis
       Patient is passive        Patient’s active role
        recipient                 Giver of treatment
                                  Presumably asleep
                                  troubleshooting
Nocturnal Home Hemodialysis

 Considerations for device design:

  Redundancy
  Additional safety alarms may become
  necessary
      Loudness
      Sensitivity
      Ease of understanding and correction
  User friendly
Nocturnal Home Hemodialysis
Consider the following additional safety features:

   Safeguard to prevent blood access
    disconnections or air emboli
   Type of vascular access
   Alarms to detect fluid leaks
   Moisture detector
   Software to include remote monitoring
   User-friendly instructions
   Displayed screen with menus
Nocturnal Home Hemodialysis
Human Factors Issues

 User-friendly
 Dispose of devices safely and
  effectively with minimal dangerous
  error
 Minimal dependance on labeling and
  training
Nocturnal Home Hemodialysis
 Water Quality concerns

  Conventional hemodialysis: 360L/week
  Nocturnal Hemodialysis: 648L-
   1080L/week
  Types of water treatment systems
    Reverse osmosis (RO)
    Deionization (DI)
    Combination
Nocturnal Home Hemodialysis

 Water Quality concerns

  Standard water quality for hemodialysis
   vs. higher standards
  Type of water treatment system
  Water source
      Municipal water suppliers
      Well water
Nocturnal Home Hemodialysis
Issues on monitoring
 Without a partner*
 In-center hemodialysis – constant
    monitoring
   Home hemodialysis


* Raija, et.al. Experiences on Home Hemodialysis without an
    Assistant. Hemodialysis International 2003; 7(1):73-104.
Nocturnal Home Hemodialysis

 Issues on monitoring

 “Monitoring is essential for the initial 3 months
   of nocturnal HD therapy until the HD team is
   convinced the patient is stable and
   compliant.”


   * The London Daily/Nocturnal Hemodialysis Study. AJKD, 2003
Nocturnal Home Hemodialysis

Vascular access

   Arteriovenous fistula
   Synthetic graft
   Long-term cuffed catheter
Nocturnal Home Hemodialysis

Vascular access

   Arteriovenous fistula
   Synthetic graft
   Long-term cuffed catheter
Nocturnal Home Hemodialysis

Vascular access

      Arteriovenous fistula*
      Synthetic graft
      Long-term cuffed catheter

  * Quintaliani, et. al.,
                       Survival of vascular access during daily
       and three times a week hemodialysis. Clin Nephrol 2000;
       53:372-377.
Nocturnal Home Hemodialysis

   Vascular access location
   Connection to the device
   Self cannulation
   Locking devices
   Enuresis alarms
   Moisture sensors
   Single vs dual needle technique
Nocturnal Home Hemodialysis
Labeling
 Operator’s Manual
     Warnings
     Cautions and Precautions
     Device specifications
     Instructions for maintenance
     Cleaning and Disinfection
 Patient Labeling
 Physician’s Labeling
 Additional risks
Nocturnal Home Hemodialysis
Additional risks

 Inadvertent disconnections
 Blood loss from increased frequency of
  treatments
 Potential increased rate of vascular access
  infection
 Psychological effects
Nocturnal Home Hemodialysis

Lay user training
 Conduct safe and effective NHD
      treatments
     Length of training reported to be
      approx 2-8 weeks* φ

* Agar, et. al., Hemodialysis International 2003; 7(4):278-289.
Φ   Leitch, et. al., Am J Kidney Dis 2003; 42(1):S56-60.
Nocturnal Home Hemodialysis
 Lay-user training

  Appropriate use of the hemodialysis
     device
    Interpretation and use of safety
     features, accessories and
     hemodialysis treatment itself
Nocturnal Home Hemodialysis
Lay-user training
 Water purification system
 Catheter lock boxes
 Moisture sensors
 Monitoring device
 Vascular access connection
   techniques
 Test the adequacy of the training
Overview

 1. Background Information
 2. Nocturnal Home Hemodialysis
 3. Clinical Studies
Overview

 1. Background Information
 2. Nocturnal Home Hemodialysis
 3. Clinical Studies
Clinical Studies

 Purpose
 Patient selection
 Study design
Clinical Studies

Purpose

To demonstrate the safety and
effectiveness of the NHD devices
under actual use conditions.
Clinical Studies

 FDA concerns:

    Outcomes
    Clearance rates
    Findings
    Adverse events
    Training
Clinical Studies
 Reported patient selection:

 Agar , et. al., Nocturnal Hemodialysis in Australia.
  Hemodialysis International 2003; 7(4):278-289.

 Alloatti, et. al., Long Nocturnal Dialysis.   Blood Purif
  2002; 20:525-530.

 Covic, et.al., Long-hours home haemodialysis – the
  best renal replacement therapy method? Q J Med
  1999; 92:251-260.
Clinical Studies

 FDA concerns:

  Patient selection for trial
  Patient selection for marketing
  Patient performs the entire treatment
  Patient must wake up to attend the
  alarms
Clinical Studies
Patient selection criteria:
   Home environment
     Water supply
     Sewage
     Electricity
     Space
     Social interaction

•   Patient's vascular access type and location
•   Availability of a partner
•   Patient's compliance
•   Psychological well being
Clinical Studies
 Study design:
  Control group
  Sample size
  Length of follow up
  Clinical endpoints
  Evaluation of outcomes
  Target patient population
Clinical Studies
Other issues to be considered:

   Dialysate composition and additives
   Type of anticoagulation
   Choice of dialyzer
   Type of monitoring
   Need of a partner
   Vascular access
   Reuse
Conclusion
 Nocturnal Home Hemodialysis Devices
  Safety is a primary concern
  Increased demands on patient and
   patient’s home/family should be assessed
  Treatment may only be available to a
   selected population
  Design of the clinical studies to
   demonstrate the safety and effectiveness
   of the device under actual use conditions
   should be discussed
References
1.   United States Renal Data System (USRDS) www.usrds.org

2.   Lockridge RS, Spencer M, Craft V, Pipkin M, Campbell D,
     McPhatter L, Albert J, Anderson H, Jennings F, and Barger T.
     Nocturnal Home Hemodialysis in North America. Adv Ren
     Replace Ther 2001; 8(4):250-256.

3.   Pierratos, A. Nocturnal home haemodialysis: an update on a 5-
     year experience. Nephrol Dial Transplant 1999; 14:2835-2840

4.   Mehrabian S, Morgan D, Schlaeper C, Kortas C, and Lindsay
     RM. Equipment and water treatment considerations for the
     provision of quotidian home hemodialysis. Am J Kidney Dis
     2003; 42:S66-S70.

5.   Raija M, Riitta MK, Meeri K, and Eero H. Experiences on Home
     Hemodialysis without an Assistant. Hemodialysis International
     2003; 7(1):73-104.
References
6.   Heidenheim AP, Leitch R, Kortas C and Lindsay RM. Patient
     Monitoring in the London Daily/Nocturnal Hemodialysis Study.
     Am J Kidney Dis 2003; 42:S61-S65.

7.   Quintaliani G, Buoncristiani U, Fagugli R, Kuluiranu H, Ciao G,
     Rondini L, Lowenthal DT, and Reboldi G. Survival of vascular
     access during daily and three times a week hemodialysis. Clin
     Nephrol 2000; 53:372-377.

8.   Agar JWM, Somerville CA, Dwyer KM, Simmonds RE,
     Boddington JM, and Waldron CM. Nocturnal Hemodialysis in
     Australia. Hemodialysis International 2003; 7(4):278-289.

9.   Leitch R, Ouwendyk M, Ferguson E, Clement L, Peters K,
     Heidenheim AP, and Lindsay RM. Nursing Issues Related to
     Patient Selection, Vascular Access, and Education in Quotidian
     Hemodialysis. Am J Kidney Dis 2003; 42(1):S56-60.
References
10.   Alloatti S, Molino A, Manes M, Bonfant G, and Pellu V. Long
      Nocturnal Dialysis. Blood Purif 2002; 20:525-530.

11.   Covic A, Goldsmith DJA, Venning MC, and Ackrill P. Long-
      hours home haemodialysis – the best renal replacement therapy
      method? Q J Med 1999; 92:251-260.

12.   The following articles have not been cited in the above
      discussion of NHD, but may provide additional information.
      Copies of these may also be found in Appendix F.

13.   Chan CT, Hanly P, Gabor J, Picton P, Pierratos A, and Floras JS.
      Nocturnal Hemodialysis Lowers Heart Rate during Sleep and
      Normalizes Its Parasympathetic and Sympathetic Modulation.
      Hemodialysis International 2003; 7(1):73-104.
References
14.   Faratro R and Chan CT. Nocturnal Hemodialysis Improves
      Productivity of End-Stage Renal Failure Patients.
      Hemodialysis International, 2003; 7(1):73-104.

15.   Francoeur R and Digiambatista A. Technical Considerations
      for Short Daily Home Hemodialysis and Nocturnal Home
      Hemodialysis. Adv Ren Replace Ther 2001; 8(4):268-272.

16.   Heidenheim AP, Muirhead N, Moist L, and Lindsay RM.
      Patient Quality of Life on Quotidian Hemodialysis. Am J
      Kidney Dis 2003; 42:S36-S41.

17.   Kjellstrand CM and Ing T. Daily Hemodialysis: History and
      Revival of a Superior Dialysis Method. ASAIO Journal 1998;
      117-122.
References
 18.   Kjellstrand CM and Blagg CR. Differences in Dialysis
       Practice are the Main Reasons for the High Mortality Rate in
       the United States compared to Japan. Hemodialysis
       International 2003; 7(1):67-71.

 19.   Kroeker A, Clark WF, Heidenheim AP, Kuenzig L, Leitch R,
       Meyette M, Muirhead N, Ryan H, Welch R, White S, and
       Lindsay RM. An Operating Cost Comparison Between
       Conventional and Home Quotidian Hemodialysis. Am J
       Kidney Dis 2003; 42:S49-S55.

 20.   Lindsay RM, Leitch R, Heidenheim AP, and Kortas C. The
       London Daily/Nocturnal Hemodialysis Study – Study Design,
       Morbidity, and Mortality Results. Am J Kidney Dis 2003;
       42(1):S5-S12.
References
21.   Lindsay RM, Alhejaili F, Nesrallah G, Leitch R, Clement L,
      Heidenheim AP, and Kortas C. Calcium and Phosphate
      Balance with Quotidian Hemodialysis. Am J Kidney Dis
      2003; 42, S1:S24-29.

22.   Nesrallah G, Suri R, Moist L, Kortas C, and Lindsay RM.
      Volume Control and Blood Pressure Management in Patients
      Undergoing Quotidian Hemodialysis. Am J Kidney Dis 2003;
      42:S13-17.

23.   Pierratos A. Daily nocturnal home hemodialysis. Kidney
      International 2004; 65:1975-1986.

24.   Pierratos A. Quotidian Hemodialysis: Is it the Solution to the
      Problem? Seminars in Dialysis 2004; 17(2):77-78.
References
25.   Radford MG, Shultman DS, Pasour AG, Cobb AM, and
      Chandler JT. An Incenter Nocturnal Hemodialysis Program
      – Three Years Experience. Hemodialysis International 2003;
      7(1):73-104.

26.   Rao M, Muirhead N, Klarenbach S, Moist L, and Lindsay RM.
      Management of Anemia with Quotidian Hemodialysis. Am J
      Kidney Dis 2003; 42:S18-S23.

27.   Spanner E, Suri R, Heidenheim AP, and Lindsay RM. The
      Impact of Quotidian Hemodialysis on Nutrition. Am J Kidney
      Dis 2003; 42(1):S30-S35.
References
 28. Suri R, Depner TA, Blake PG, Heidenheim AP, and
     Lindsay RM. Adequacy of Quotidian
     Hemodialysis. Am J Kidney Dis 2003; 42:S42-S48.

 29. Van Biesen W, Veys N, Vanholder R, and Lameire
     N. Effect of Long Nocturnal Dialysis on Nutritional
     Status and Blood Pressure Control. Hemodialysis
     International, 2003; 7(1):73-104.

 30. Weick-Brady M. Medical Devices: Going Home.
     FDLI Update 2003; September/October: 23-24, 29-
     30.
References
 31. Weinger MB, Foreword to Designing Usability
     into Medical Products

 32. Woods JD, Port FK, Stannard D, Blagg CR, and
     Held PJ. Comparison of mortality with home
     hemodialysis and center hemodialysis: A
     national study. Kidney International, 1996;
     49:1464-1470.

 33. Young BA, Hynes J, and McComb T. Home
     Hemodialysis: Associations with Modality
     Failure. Hemodialysis International, 2003; 7:73-
     104.

				
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