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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
SUBJECT
 Before this landmark trial, there were just non-randomized observational studies
 Prior studies showed mixed survival benefit on early initiation of dialysis
QUESTION
 In person with stageV CKD, is there a difference in survival or clinical outcomes
between early or late initiation of dialysis?
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
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
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)
CRITICISMS
 No standardized assessment of creatinine was used
 The Cockcroft-Gault equation was used rather than MDRD (more accurate
assessment of GFR)
BOTTOM LINE
 In patients w/ StageV CKD, there was no difference in survival or clinical
outcome between initiating dialysis earlier vs. later.
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?
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?

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SALT-E 3

  • 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?