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

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

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

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

5. pCRRT Multi-Center Registry Data Effective April 1, 2002 Current Registry Centers and PI 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

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

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

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

9. pCRRT Multi-Center Registry Data Effective April 1, 2002 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/1.73m 2 /hour Nutrition prescription –Kcal/kg/day –Grams protein/kg/day

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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