Published on May 13, 2016
1. IDEAL: A RANDOMIZED, CONTROLLEDTRIAL OF EARLYVERSUS LATE INITIATION OF DIALYSIS COOPER BA, ET AL. "A RANDOMIZED, CONTROLLED TRIAL OF EARLYVERSUS LATE INITIATION OF DIALYSIS". THE NEW ENGLAND JOURNAL OF MEDICINE. 2010. 363(7):609-619. SALTE E: OVMC LANDMARK TRIAL SERIES 2016 HTTP://TINYURL.COM/SALTE3
2. SUBJECT Before this landmark trial, there were just non-randomized observational studies Prior studies showed mixed survival benefit on early initiation of dialysis
3. QUESTION In person with stageV CKD, is there a difference in survival or clinical outcomes between early or late initiation of dialysis?
4. DESIGN Multicenter, parallel-group, randomized, controlled trial Year: 2000-2008 Location: 32 centers in Australia and New Zealand Duration: 3.6 years follow up Analysis: intention-to-treat
5. POPULATION Subjects: 828 patients w/ StageV CKD Early dialysis: (n=404) GFR 10-14 ml/min Late dialysis: (n=424) GFR 5-7 ml/min OR physicians’ discretion (uremic symptom,or electrolyte) Regimen of peritoneal dialysis vs. hemodialysis at discretion of physician and patient
6. OUTCOME Primary Outcome All-cause mortality: 10.2 (early) vs. 9.8 (late) (HR 1.04, p = 0.75) Secondary Outcome CV events (CV death, nonfatal MI/stroke/TIA/angina): 10.9 vs. 8.8 (HR 1.23, p=0.09) ID events (death form infection, hospitalization): 12.4 vs. 14.3 (HR 0.87, p=0.2) Temporary catheter placement: 10 vs. 9.7 (p=0.85) Need for access revision: 13.2 vs. 12.4 (p=0.54) Serious fluid or electrolyte disorder: 13.2 vs. 15 (p=0.26) Time to initiation of dialysis: 1.8 vs. 7.4 months (HR 2.09, p<0.001)
7. CRITICISMS No standardized assessment of creatinine was used The Cockcroft-Gault equation was used rather than MDRD (more accurate assessment of GFR)
8. BOTTOM LINE In patients w/ StageV CKD, there was no difference in survival or clinical outcome between initiating dialysis earlier vs. later.
9. DISCUSSION QUESTIONS In this study, what are the two criteria of GFR ranges that help to assign patient to early vs. late trials? What are the indications to start dialysis in late arm? In which arms (early vs. late) would you expect the composite infectious events to be significantly higher? What are the primary outcome of this study What is one criticism of this study?
10. CLINICAL APPLICATION A stageV CKD pt was admitted to your team for SOB, with x-ray showing enlarged heart and bilateral cephalization of pulmonary vessels. PE significant for sacral and pitting edema. Lab significant for potassium 5.6, BUN 50, GFR 10. You are renal consult.Would you recommend to start dialysis or not?