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The Prospective Pediatric CRRT (ppCRRT) Registry

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?.

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The Prospective Pediatric CRRT (ppCRRT) Registry

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  1. 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

  2. How did the ppCRRT registry come to exist? • Stu Goldstein MD originated the concept and identified a group who work well together to • Initially look at “what is being done as standard of practice ” • Perform studies on • New devices • Drug clearance • What can be done in the future

  3. The Founding Five Bunchman Brophy Goldstein Symons Somers

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

  5. ppCRRT Sponsors The ppCRRT Registry receives grant funding from Gambro Renal Products Dialysis Solutions, Incorporated Baxter Healthcare B Braun, Inc

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. Percent Fluid Overload Calculation [ ] Fluid In - Fluid Out ICU Admit Weight * 100% % FO at CVVH initiation = Fluid In = Total Input from ICU admit to CRRT initiation Fluid Out = Total Output from ICU admit to CRRT initiation

  13. Registry PICU Data • Cardiopulmonary • Maximum inotrope doses • Pressors weaned? (yes/no) • MAP change • ICU length of stay

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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 • Seattle Children’s • UAB • University of Michigan • Mercy Children’s, KC • Egleston Children’s, Atlanta • All Children’s, Tampa • DC Children’s • Columbus Children’s • Packard Children’s, Palo Alto • DeVos Children’s, Grand Rapids

  19. Fluid Overload and CRRT

  20. 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)

  21. Percent Fluid Overload Calculation [ ] Fluid In - Fluid Out ICU Admit Weight * 100% % FO at CVVH initiation = 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

  22. 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)

  23. N=113 *p=0.02; **p=0.01

  24. Kaplan-Meier survival estimates, by percentage fluid overload category

  25. 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

  26. Anticoagulation and CRRT • Heparin and citrate anticoagulation most commonly used methods • Heparin: bleeding risk • Citrate: alkalosis, citrate lock

  27. (Ca = 0.4 x citrate rate 60 mls/hr) (Citrate = 1.5 x BFR 150 mls/hr) Pediatr Neph 2002, 17:150-154 (BFR = 100 mls/min) Normal Saline Replacement Fluid Calcium can be infused in 3rd lumen of triple lumen access if available. Normocarb Dialysate • ACD-A/Normocarb Wt range 2.8 kg – 115 kg • Average life of circuit on citrate 72 hrs (range 24-143 hrs)

  28. 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

  29. 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

  30. 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

  31. Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121

  32. Hackbarth R et al: IJAIO Dec 2007, 30: 1116-1121

  33. 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

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

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

  36. At high risk for death with AKI needing CRRT • Fluid overload >12% associated with mortality in BMT patients with AKI

  37. 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

  38. 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

  39. 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

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