MUNICH, GERMANY—Planned early initiation of dialysis does not improve survival or clinical outcomes among patients with end-stage renal disease, study findings show.
Investigators presented their findings of the Initiating Dialysis Early and Late (IDEAL) study during a symposium at the European Renal Association-European Dialysis and Transplant Association 2010 Congress, where one of the symposium’s moderators, Johannes F.E. Mann, MD, of University of Erlangen Medical Center and KfH Kidney Center, Munich, Germany, said the results “will shake the nephrology world for some time.”
The study, presented by lead investigator Bruce A. Cooper, MB, BS, PhD, of Royal North Shore Hospital in St. Leonards, New South Wales, Australia, was conducted at 32 centers in Australia and New Zealand. The researchers randomized 828 adults (542 men and 286 women) to start dialysis when their estimated glomerular filtration rate (eGFR) was 10-14 mL/min (early start) or when their eGFR declined to 5-7 mL/min (late start).
Subjects had a mean age of 60.4 years. The median time to initiation of dialysis was 1.8 months in the early-start group compared with 7.4 months in the late-start group. Nearly 76% of patients in the late-start group started dialysis when their estimated eGFR was the 7 mL/min target because of the development of symptoms. Of the 404 patients assigned to early-start dialysis, 383 started dialysis; of the 424 patients assigned to late-start dialysis, 386 started dialysis.
After a median follow-up of 3.59 years, the two groups showed no significant differences in the primary outcome of all-cause mortality or the secondary outcomes of cardiovascular and infectious events and dialysis complications, said Dr. Cooper, who told listeners that dialysis should not be started on the basis of GFR alone.
His presentation coincided with the study’s publication in the New England Journal of Medicine. The researchers noted that, according to U.S. Renal Data System, the proportion of patients who started dialysis when the eGFR was above 10 mL/min rose from 19% in 1996 to 45% in 2005. “Our results indicate that such trends toward early initiation of dialysis, which have enough implications in terms of cost and infrastructure of dialysis services, are unlikely to improve clinical outcomes,” the authors wrote.
At a press conference following Dr. Cooper’s presentation, Norbert H. Lamiere, MD, PhD, Professor Emeritus of Medicine at the University of Ghent in Belgium, who co-wrote an accompanying editorial in NEJM, called the study “a landmark paper.”
“This is obviously a fantastic study,” Dr. Lamiere said, adding that the findings suggest that “clinical symptoms should dictate the start of dialysis.”