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 A Randomized, Controlled Trial of Early Versus Lat

Publication Date : Jun 28, 2010

Study Question:

What is the influence of the timing of the initiation of maintenance dialysis on survival among patients with chronic kidney disease?

Methods:

The Initiating Dialysis Early and Late (IDEAL) study investigators randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (eGFR) between 10.0-15.0 ml/min/1.73 m2 of body-surface area (calculated with the use of the Cockcroft–Gault equation) to planned initiation of dialysis when the eGFR was 10.0-14.0 ml/min (early start) or when the eGFR was 5.0-7.0 ml/min (late start). The primary outcome was death from any cause.

Results:

Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60-2.23) in the early-start group and 7.40 months (95% CI, 6.23-8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the eGFR was above the target of 7.0 ml/min, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83-1.30; p = 0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis).

Conclusions:

The authors concluded that planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes.

Perspective:

In this study involving patients with chronic kidney disease, early initiation of dialysis had no significant effect on the rate of death from any cause or on cardiovascular events, infectious events, or complications of dialysis. The results suggest that with careful clinical management of chronic kidney disease, dialysis can be delayed for some patients until the GFR drops below 7.0 ml/min or until more traditional clinical indicators for the initiation of dialysis are present. It should be noted that the majority of the patients assigned to the late-start group did not commence dialysis at the level of GFR defined in the protocol, and the mean difference in eGFR was only 2.2 ml/min. However, there was a difference of 6 months between the groups in the start time for dialysis, reflecting the critical importance of close clinical follow-up if dialysis is to be delayed.

Author(s):

Debabrata Mukherjee, M.D., F.A.C.C.

Topic(s):

General Cardiology