Multi-Center Pediatric CRRT Registry

1. Multi-Center Pediatric CRRT Registry Stuart L. Goldstein, MD Assistant Professor of Pediatrics Baylor College of Medicine pCRRT Multi-Center Registry Data Effective April 1, 2002

2. Overview • Registry study phases • Study design • Study aims • Current participating centers • Institutional practice protocol variation • Current data analysis pCRRT Multi-Center Registry Data Effective April 1, 2002

3. pCRRT Registry: Phase 1 Design • Collect prospective data from 5 to 10 pediatric centers treating 15 to 20 patients annually (200-300 patients over 3 years) • Each center follows own institutional practice • Patient selection • Initiation and termination • Anti-coagulation protocols • Convection versus diffusion versus hemodiafiltration • Fluid composition • Cytokine clearance study pCRRT Multi-Center Registry Data Effective April 1, 2002

4. pCRRT Registry: Phase 1 Aims • Assess for potential associations between various practices and pediatric patient outcomes • Assess for potential associations between varying practices and CRRT machine functioning • Determine CRRT clearance rates of various SIRS and CARS cytokines in children with sepsis pCRRT Multi-Center Registry Data Effective April 1, 2002

5. Texas Children’s Hospital (January 2001) Boston Children’s Hospital (March 2001) Seattle Children’s Hospital (July 2001) Univ of Alabama Children’s (July 2001) Univ of Michigan (December 2002) Stuart Goldstein, MD Michael Somers, MD Jordan Symons, MD Timothy Bunchman, MD Patrick Brophy, MD Melissa Gregory, MD Current Registry Centers and PI pCRRT Multi-Center Registry Data Effective April 1, 2002

6. Pre-CRRT Registry Data • Demographics • Primary disease, co-morbid illness, age, gender, days in PICU • CRRT specifics • Treatment or prevention of fluid overload and/or electrolyte imbalance • Access size and site • Renal failure indices • GFR (Schwartz) • Percent fluid overload (%FO) • Urine output in previous 24 hours pCRRT Multi-Center Registry Data Effective April 1, 2002

7. Registry PICU Data • PRISM 2 at ICU admission and CRRT initiation • CRRT initiation • CVP • MAP • Pressor number and specific drugs • Diuretic use • CRRT course • Maximum pressor number • MAP change • Pressors weaned? pCRRT Multi-Center Registry Data Effective April 1, 2002

8. pCRRT Registry Circuit Data • Separate data page for each circuit • Machine brand • Extracorporeal volume • Priming fluid • NS • albumin • blood mixed with • FFP, albumin, or bicarbonate • Dialysis or replacement fluid composition • Normocarb™ (Dialysis Solutions, Inc) • Baxter hemofiltration fluid™ • Saline, Ringer’s lactate, peritoneal dialysis fluid pCRRT Multi-Center Registry Data Effective April 1, 2002

9. pCRRT Registry Circuit Data • Anticoagulation • Citrate • Heparin rate • ACT measured per hour • Mean ACT • # ACT < 180 seconds • Clearance prescription • CVVH versus CVVHD versus CVVHDF • ml/1.73m2/hour • Nutrition prescription • Kcal/kg/day • Grams protein/kg/day pCRRT Multi-Center Registry Data Effective April 1, 2002

10. pCRRT 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 pCRRT Multi-Center Registry Data Effective April 1, 2002

11. pCRRT 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 pCRRT Multi-Center Registry Data Effective April 1, 2002

12. pCRRT Registry: Results (4/1/2002) • 42 patients entered into study • 36 with complete data • 128 circuits • 4905 cumulative treatment hours • Mean 41.2 + 28.9 hours • Range 1 to 118 hours pCRRT Multi-Center Registry Data Effective April 1, 2002

13. Baseline Demographics pCRRT Multi-Center Registry Data Effective April 1, 2002

14. Registry Center Census pCRRT Multi-Center Registry Data Effective April 1, 2002

15. Primary Disease pCRRT Multi-Center Registry Data Effective April 1, 2002

16. pCRRT Registry Modality pCRRT Multi-Center Registry Data Effective April 1, 2002

17. Reason to Start CRRT pCRRT Multi-Center Registry Data Effective April 1, 2002

18. Outcome pCRRT Multi-Center Registry Data Effective April 1, 2002

19. Clinical Variables and Outcome • Survival not associated with • GFR • Pressor number • MAP • PRISM at ICU admission • Age • Weight • Survival associated with • PRISM at CRRT initiation • % Fluid overload at CRRT initiation pCRRT Multi-Center Registry Data Effective April 1, 2002

20. PRISM at CRRT Initiation and Outcome P < 0.0005 pCRRT Multi-Center Registry Data Effective April 1, 2002

21. Fluid Overload and Outcome P < 0.05 pCRRT Multi-Center Registry Data Effective April 1, 2002

22. Fluid Overload and Outcome:Renal Failure Only P < 0.05 pCRRT Multi-Center Registry Data Effective April 1, 2002

23. Fluid Overload, Severity of Illness and Outcome • Greater degrees of fluid overload associated with death, even when controlled for severity of illness by PRISM score (multiple regression analysis; p<0.03) pCRRT Multi-Center Registry Data Effective April 1, 2002

24. Circuit Change Reason pCRRT Multi-Center Registry Data Effective April 1, 2002

25. Anticoagulation Method and Circuit Life N=69 N=38 P < 0.003 pCRRT Multi-Center Registry Data Effective April 1, 2002

26. pCRRT Registry Future Phases • Assess association between nutrition and outcome • Assess cytokine levels and clearance • Test new products devices safely and efficiently • Prospective randomized trials • Dose • Fluid options • Selective cytokine removal • Time to intervention • Disease-specific protocol and outcome • Web-based for easy access and query pCRRT Multi-Center Registry Data Effective April 1, 2002