(HealthDay News) — Intervention uptake was insufficient to allow evaluation of its impact in a pragmatic trial designed to assess the effect of longer hemodialysis duration on death and other outcomes; the findings from the Time to Reduce Mortality in ESRD (TiME) trial were published online in the Journal of the American Society of Nephrology.
Laura M. Dember, MD, from the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues performed a cluster-randomized, pragmatic trial demonstration project to develop approaches for embedding trials into routine delivery to assess the effects of maintenance hemodialysis session duration. Dialysis facilities randomly assigned to the intervention adopted a default session duration of ≥255 minutes, while those randomly assigned to usual care had no trial-driven approach to duration. Multiple strategies were used to engage facility personnel and participating patients. A total of 7035 incident patients from 266 dialysis units were enrolled.
The trial was discontinued at a median follow-up of 1.1 years due to an inadequate between-group difference in session duration. The researchers found that mean session durations were 216 and 207 minutes for the intervention and usual care groups, respectively, in the primary analysis population (participants with estimated body water ≤42.5 L). Compared with usual care, there was no reduction in mortality or hospitalization rate for the intervention.
“There is a pressing need for data from randomized trials to guide clinical practice in dialysis,” Dember said in a statement. “Pragmatic trials embedded in clinical care delivery have tremendous potential for efficiently producing evidence that is highly generalizable to the nonresearch setting; however, experience with this approach is limited. The TiME trial provides an important foundation for future pragmatic trials in dialysis as well as in other settings.”
Several authors disclosed financial ties to the pharmaceutical industry.