IDEAL:

A RANDOMIZED, CONTROLLED TRIAL

OF EARLY VERSUS LATE INITIATION OF

DIALYSISCOOPER BA, ET AL. "A RANDOMIZED, CONTROLLED TRIAL OF EARLY VERSUS 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 stage V 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/ Stage V 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/ Stage V 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 stage V 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?