Researchers incorporate a randomized study into dialysis care

A recent clinical study fully integrated with routine care in dialysis facilities sought to determine whether hemodialysis sessions that are longer than many patients in the United States currently receive can improve patients' health. Although the trial performed most of its goals, acceptance of the intervention was insufficient to determine if the longer sessions were beneficial. The results, which appear in an upcoming issue of JASN, indicate that the incorporation of trials into dialysis care will require more effective strategies to involve clinicians and patients.

The study's researchers had two goals: to develop approaches to incorporate large randomized trials into the routine delivery of clinical care and to determine if patients benefit from hemodialysis sessions longer than normal. In the time to reduce mortality in the ESRD (TiME) study, 266 randomized dialysis facilities for intervention adopted a standard duration of the hemodialysis session of at least 4.25 hours for new dialysis patients; those randomized to usual care had no specific approach to duration. The implementation of the evaluation was highly centralized, with no on-site research staff and total reliance on clinically acquired data.

The team demonstrated that a test built into clinical care without an on-site research team could efficiently enroll a large number of participants using an informed consent deactivation approach. (The study involved 7,035 patients.) The study also was able to obtain useful data on the treatment and outcomes of hundreds of medical facilities and to monitor the conduct and safety of the studies through a centralized approach.

The trial was discontinued at a mean follow-up of 1.1 years because of an inappropriate difference between groups in the duration of the session. The mean duration of the session was 216 minutes for the intervention group and 207 minutes for the usual care group. The researchers found no reduction in mortality or hospitalization rates for the intervention versus usual care.

"There is an urgent need for data from randomized clinical trials to guide clinical practice in dialysis," said lead author Laura M. Dember, MD (University of Pennsylvania Perelman School of Medicine). "Pragmatic assays embedded in clinical care delivery have a tremendous potential to produce evidence that is highly generalizable to the non-research setting, but experience with this approach is limited. pragmatic studies in dialysis, as in other settings. "