The Prospective Pediatric CRRT (ppCRRT) Registry by HC111123165117

VIEWS: 22 PAGES: 45

									  The Prospective Pediatric CRRT
  (ppCRRT) Registry
Stuart L. Goldstein, MD Principal Investigator and Founder




       Timothy E Bunchman
       Helen DeVos Children’s Hospital
       Grand Rapids MI USA
How did the ppCRRT registry come
to exist?
   Stu Goldstein MD originated the concept and
    identified a group who work well together to
              look at “what is being done as standard of
     Initially
      practice ”
     Perform studies on
           New devices
           Drug clearance
     What can     be done in the future
           The Founding Five




Bunchman    Brophy   Goldstein   Symons   Somers
Co-Investigators/Data Coordinators
   • Michael Somers   • James Fortenberry
   • Michelle Baum    • Kristine Rogers
   • Cheryl Baker     • Renee Robinson
   • Pat Brophy       • John Mahan
   • Theresa Mottes   • Deepa Chand
   • Jordan Symons    • Francisco Flores
   • Nancy McAfee     • Kevin McBryde
   • Tim Bunchman     • Steven Alexander
   • Rick Hackbarth   • Annabelle Chua
   • Dawn Eding       • Douglas Blowey
   • Mark Benfield    • Stuart Goldstein
   • David Askenazi
ppCRRT Sponsors

     The ppCRRT Registry receives
          grant funding from
       Gambro Renal Products
    Dialysis Solutions, Incorporated
          Baxter Healthcare
             B Braun, Inc
ppCRRT Registry: Phase 1
Observational Data
   Assess for potential associations between
    various practices and pediatric patient
    outcomes in 300 patients
   Assess for potential associations between
    varying practices and CRRT machine
    functioning
ppCRRT Registry Design
 Prospective, observational format
 Informed consent required
 All centers practice according to their
  local protocol with respect to
     initiation   and termination criteria
     modality
     prescription
        clearance
        fluids

        anticoagulation
ppCRRT Data Collected

   Divided into three electronic or paper forms
     Pre-Initiation/Demographic   Data
     ICU  data
     Filter data
   Each patient has unique identifier to describe
    center site and patient number (e.g., the third
    Texas Children’s patient is #1003)
   Some sites’ IRB’s prevent listing date of birth, so
    investigator calculates age
    Pre-CRRT Registry Data
   Demographics
     primary disease leading to CRRT
     co-morbid illness
     MODS (yes/no)
     gender
     days in PICU prior to CRRT
     ICU admit weight and height/length
   CRRT specifics
     Modality
     CRRT reason(s)
        Treatment or prevention of fluid overload and/or

        Treatment or prevention of electrolyte imbalance

     Access    size, configuration and site
   Pediatric Risk of Mortality 2 (PRISM 2) score
    PRISM 2 score
       14 variables, 5 organ domains
         Cardiovascular   (SBP, DBP, pulse)
         Respiratory (Resp rate, pO2, pCO2)
         Neurological (Glasgow Coma score, pupillary
          reaction)
         Hepatic (bilirubin)
         Metabolic (potassium, calcium, total CO2, glucose)

       Direct assessment of renal function not included
       Easy to calculate
       Data remains with ppCRRT and not sent
        elsewhere for analysis
Pollack M: Crit Care Med. 1988 16:1110-6
Pre-CRRT Registry Data:
CRRT Initiation
   Renal failure indices at CRRT initiation
     GFR (Schwartz)
     Urine output   in previous 24 hours
   Percent fluid overload (%FO)
   PRISM 2 score
   CVP
   Mean airway pressure
   Number of inotropic agents used
   Diuretics? (yes/no)
     Percent Fluid Overload Calculation

% FO at CVVH initiation =[   Fluid In - Fluid Out
                             ICU Admit Weight       ]   * 100%




 Fluid In = Total Input from ICU admit to CRRT initiation
 Fluid Out = Total Output from ICU admit to CRRT initiation
    Registry PICU Data

   Cardiopulmonary
     Maximum   inotrope doses
     Pressors weaned? (yes/no)
     MAP change

   ICU length of stay
ppCRRT Registry Circuit Data
   Separate dataset for each circuit
   Machine brand
   Extracorporeal circuit volume
   Priming fluid
   Dialysis or replacement fluid composition
   Anticoagulation
     Citrate
     Heparin rate
        ACT measured per hour

        Mean ACT

        # ACT < 180 seconds
ppCRRT Registry Circuit Data
   Clearance prescription
     CVVH   versus CVVHD versus CVVHDF
     ml/1.73m2/hour

   Nutrition prescription at each circuit initiation
     Kcal/kg/day
     Grams   protein/kg/day
   Total fluid intake
   Total fluid output
   Total and net ultrafiltration
   Percent blood volume UF’d per hour
ppCRRT Registry Patient Data:
Outcome
   Survival versus death (discharge from PICU)
   Attainment of target dry weight
   Reason to discontinue CRRT
     Death
     Regained   renal function
     Underlying illness resolved
     Tolerates intermittent hemodialysis
ppCRRT Registry Circuit Data:
Outcome
 Filter life-span (hours)
 Reason for circuit change
     clotting
     access  malfunction
     machine malfunction
     unrelated patient indication (e.g., needs CT
      scan)
     CRRT discontinued
ppCRRT Experience
   First patient enrolled on 1/1/01
   376 patients entered into database as of
    07/31/05 (study end)
   342 with complete data
   >60,000 hours of CRRT

    –Texas Children’s
    –Boston Children’s              –All Children’s, Tampa
    –Seattle Children’s             –DC Children’s
    –UAB                            –Columbus Children’s
    –University of Michigan         –Packard Children’s, Palo Alto
    –Mercy Children’s, KC           –DeVos Children’s, Grand Rapids
    –Egleston Children’s, Atlanta
Fluid Overload and CRRT
   22 pt (12 male/10 female) received 23 courses (3028 hrs) of
    CVVH (n=10) or CVVHD (n=12) over study period.
   Overall survival was 41% (9/22).
   Survival in septic patients was 45% (5/11).
   PRISM scores at ICU admission and CVVH initiation were 13.5
    +/- 5.7 and 15.7 +/- 9.0, respectively (p=NS).
   Conditions leading to CVVH (D)
       Sepsis (11)
       Cardiogenic shock (4)
       Hypovolemic ATN (2)
       End Stage Heart Disease (2)
       Hepatic necrosis, viral pneumonia, bowel obstruction and End-Stage
        Lung Disease (1 each)
Percent Fluid Overload Calculation




% FO at CVVH initiation =        [    Fluid In - Fluid Out
                                      ICU Admit Weight       ]   * 100%




 Fluid In = Total Input from ICU admit to CRRT initiation
 Fluid Out = Total Output from ICU admit to CRRT initiation


Goldstein SL et al: Pediatrics 2001 Jun;107(6):1309-12
   Lesser % FO at CVVH (D)
    initiation was associated with
    improved outcome (p=0.03)
   Lesser % FO at CVVH (D)
    initiation was also associated
    with improved outcome when
    sample was adjusted for
    severity of illness (p=0.03;
    multiple regression analysis)
N=113 *p=0.02; **p=0.01
Kaplan-Meier survival estimates, by percentage
fluid overload category
   Seven center study from
    the ppCRRT Registry
   116 patients with MODS
   PRISM 2 score used to
    assess patient severity of
    illness
   Survival defined at PICU
    discharge
Anticoagulation and CRRT
 Heparin and citrate anticoagulation most
  commonly used methods
 Heparin: bleeding risk
 Citrate: alkalosis, citrate lock
                                              (Ca = 0.4 x citrate rate
  (Citrate = 1.5 x BFR                        60 mls/hr)
  150 mls/hr)




                                           Pediatr Neph 2002,
                                           17:150-154




(BFR = 100 mls/min)

                               Normal            Calcium can be infused in 3 rd
                               Saline            lumen of triple lumen access if
     Normocarb                 Replaceme         available.
     Dialysate                 nt Fluid
   ACD-A/Normocarb Wt range 2.8 kg – 115 kg
   Average life of circuit on citrate 72 hrs (range 24-143 hrs)
   Seven ppCRRT centers
       138 patients/442 circuits
       3 centers: hepACG only
       2 centers: citACG only
       2 centers: switched from hepACG to citACG
   HepACG = 230 circuits
   CitACG= 158 circuits
   NoACG = 54 circuits
   Circuit survival censored for
       Scheduled change
       Unrelated patient issue
       Death/witdrawal of support
       Regain renal function/switch to intermittent HD
Access
 If you don’t have a functional access, you
  may as well go home
 Small studies show
     Short femoral catheters have greater
      recirculation
     Femoral catheters have shorter functional
      survival
  ppCRRT Access
     Data from entire ppCRRT
     Assessed for association between functional
      survival and
       Catheter size
       Catheter site
       Modality (convection        vs. diffusion)
     Femoral (69%)
     IJ (16%)
     SCV (8%)
     Not specified (7%)

Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
                                              •    p<0.03 in favor of IJ
                                              •    5 Fr removed from analysis
                                              •    All ACG
                                              •    No difference in citACG




Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
                                                   • p<0.02
                                                   • All ACG
                                                   • 8 Fr > 9Fr survival
                                                   • 9 Fr > 8 Fr femoral




Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
                                                   •   p<0.001
                                                   •   No difference in cath size or ACG
                                                   used between three modalities
                                                   •   Modality strongest predictor in Co
                                                   Proportional hazards model




Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121
   At high risk for
    death with AKI
    needing CRRT
   Fluid overload
    >12% associated
    with mortality in
    BMT patients with
    AKI
Stem Cell Transplant: ppCRRT
 51 patients in ppCRRT with SCT
 Mean %FO = 12.41 + 3.7%.
 45% survival
      Convection:   17/29 survived (59%)
      Diffusion: 6/22 (27%), p<0.05

   Survival lower in MODS and ventilated
    patients
Flores FX et al: Pediatric Nephrology 2008, 23: 625-630
    ppCRRT & SCT

   Patients kept dry prior
    to CRRT initiation
   No difference in any
    parameter at CRRT
    initiation
   Paw worse for non-
    survivors at CRRT end




Flores FX et al: Pediatric Nephrology 2008, 23: 625-630
ppCRRT
 Under the guidance of Stu this group has
  been very productive producing to data 11
  papers in CRRT
 Under the guidance of Stu we are now
  looking prospectively
     Impact of cytokine clearance by modality
     Drug clearance by modality

								
To top