Time to Reduce Mortality in End-Stage Renal Disease (TiME)

General Description

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.

Objectives

The primary objective of the TiME trial was to determine whether hemodialysis duration of a minimum of 4.25 hours (versus usual care) in patients with end-stage renal disease has benefits on mortality, hospitalizations, and health-related quality of life. The TiME trial also aimed to demonstrate the capacity to conduct large, pragmatic clinical trials with two large dialysis provider organizations.

Outcome Measure

Primary Outcome Measure: All-cause mortality by time to death
Secondary Outcome Measure: Hospitalization rate
Other Outcome Measure: Quality of life

Criteria

Inclusion Criteria:
• End-stage renal disease patients treated by hemodialysis on a thrice
weekly maintenance schedule
• Initiation of maintenance dialysis within the past 120 days
• Treatment with maintenance dialysis in a participating facility
• Age ≥ 18 years

Exclusion Criteria:
• Unwillingness to participate
• Inability to provide consent for dialysis care

Outcome

The TiME trial enrolled 7,035 incident patients from 266 dialysis units. The trial was discontinued at a median follow up of 1.1 years due to an inadequate between-group difference in session duration. No reduction in mortality or hospitalization rate was found for the Intervention arm versus the Usual Care arm.