Michael Walsh, MD, MSc
In patients with stage 5 chronic kidney disease (CKD), how do early and late initiation of maintenance dialysis compare for reduction of all-cause mortality?
Randomized controlled trial (Initiating Dialysis Early and Late [IDEAL] study). Australian New Zealand Clinical Trials Registry 12609000266268.
Blinded (outcome assessors, safety committee, and data analysts/statisticians).*
Median 3.6 years.
32 centers in Australia and New Zealand.
828 patients ≥ 18 years of age (mean age 60 y, 65% men, 43% with diabetes) who had progressive CKD and an estimated glomerular filtration rate (eGFR) of 10.0 to 15.0 mL/min/1.73 m2 of body surface area. Exclusion criteria included planned kidney transplant from a live donor within 12 months and recent diagnosis of cancer that was likely to affect survival.
Early-start dialysis commencing when eGFR was 10.0 to 14.0 mL/min (n = 404) or late-start, with routine medical care until initiation of dialysis when eGFR was 5.0 to 7.0 mL/min (n = 424). Late-start patients could commence dialysis when the eGFR was > 7.0 mL/min at the discretion of the treating physician.
All-cause mortality. Secondary outcomes included cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or new-onset angina); infectious events (death or hospitalization due to any infection-related cause); and complications of dialysis, including temporary placement of an access catheter, need for access revision, access site infection, or serious fluid and electrolyte disorder. The study had 80% power to detect a ≥ 10% difference in mortality between groups with a 3-year recruitment period and a 3-year follow-up period (α = 0.05).
92% (intention-to-treat analysis).
Early- and late-start dialysis did not differ for all-cause mortality, cardiovascular events, infectious events, or any of the measured complications of dialysis (Table).
In patients with stage 5 chronic kidney disease, early and late initiation of maintenance dialysis did not differ for all-cause mortality or other clinical outcomes.
Early- versus late-start dialysis in patients with stage 5 chronic kidney disease†
†Abbreviations defined in Glossary. RRI, RRR, NNH, NNT, and CI calculated from hazard ratios and control event rates in article.
‡Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or new-onset angina.
§Death or hospitalization due to any infection-related cause.
Walsh M. Early and late initiation of dialysis did not differ for reduction of all-cause mortality in stage 5 chronic kidney disease. Ann Intern Med. ;153:JC5–2. doi: 10.7326/0003-4819-153-10-201011160-02002
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Published: Ann Intern Med. 2010;153(10):JC5-2.
Chronic Kidney Disease, Nephrology, Renal Replacement Therapy.
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