Time to Reduce Mortality in End-Stage Renal Disease

The TiME trial was a cluster-randomized, parallel-group pragmatic clinical trial for patients initiating treatment with maintenance hemodialysis. Facilities were randomized in a 1:1 distribution to the Intervention arm or the Usual Care arm. The facilities randomized to the Intervention arm adopted the practice of recommending dialysis session durations of at least 4.25 hours for all patients, while the facilities randomized to the Usual Care arm maintained their existing recommendations for dialysis session durations. The TiME trial follow-up lasted 3 years where the primary endpoint was mortality and secondary endpoints included hospitalization and quality of life. Features of the TiME trial included high generalizability due to non-restrictive eligibility criteria, implementation of the intervention by clinical care providers instead of research personnel, and data collection conducted through routine clinical care rather than through research activities.