UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)

UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)

Overview

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Principal Investigator:
Laura Dember

Laura Dember, MD

Sponsoring Institution: University of Pennsylvania

Collaborators:

  • Fresenius Medical Care North America

  • DaVita Clinical Research

NIH Institute Providing Oversight: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Program Official: Paul Kimmel, MD (NIDDK)

Project Scientist: Kevin Abbott, MD, MPH (NIDDK)

ClinicalTrials.gov Identifier: NCT02019225

Study Locations: Dialysis facilities throughout the United States

Trial Status: Terminated

Study Snapshot

Trial Summary

Study question and significance: Although maintenance hemodialysis has been used for end-stage kidney disease for more than 50 years, there is uncertainty about the best approaches for many of the fundamental aspects of treatment, including the optimal duration of hemodialysis sessions. The objectives of the TiME trial were to evaluate the effects on mortality and hospitalization rates of hemodialysis session durations that are longer than many patients in the United States currently receive, and to establish approaches for embedding randomized clinical trials into the routine delivery of dialysis care.

Design and setting: Cluster randomized trial conducted in 266 dialysis units operated by 2 large dialysis provider organizations. Dialysis units were randomized in a 1:1 ratio to either the intervention or usual care.

Intervention and methods: Facilities randomized to the intervention adopted a default hemodialysis session duration of ≥ 4.25 hours, and facilities randomized to usual care had no trial-driven approach to session duration. Enrollment was restricted to patients new to dialysis (incident patients). The primary outcome was mortality, and the major secondary outcomes were hospitalization rate and quality of life. The trial relied entirely on clinical personnel and clinically acquired data.

Findings: The trial enrolled 7035 patients with demographic and clinical characteristics that matched those of the overall US hemodialysis patient population. The trial was discontinued after a median follow-up of 1.1 years because there was an insufficient difference in mean hemodialysis session duration between the intervention group and the usual care group. There was no reduction in mortality or hospitalization rate in the intervention group compared with usual care.

Conclusions and relevance: Although the highly pragmatic design allowed efficient participant enrollment, data acquisition, and adherence monitoring, intervention uptake was insufficient to determine whether use of longer hemodialysis sessions improves outcomes. Effective approaches for engaging clinical personnel and patients are required to evaluate interventions fully embedded in care delivery

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