A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

Study Overview
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Brief Summary
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The purpose of the TiME Trial is to determine whether dialysis facility implementation of a minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has benefits on mortality, hospitalizations and health-related quality of life. The trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial in partnership with two large dialysis provider organizations.

Detailed Description
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The TiME Trial is a cluster-randomized, parallel-group pragmatic clinical trial for patients initiating treatment with maintenance hemodialysis. Facilities will be randomized in a 1:1 distribution to the Intervention arm or the Usual Care arm. Facilities randomized to the Intervention arm will adopt the practice of recommending dialysis session durations of at least 4.25 hours for all patients initiating hemodialysis treatment regardless of body size or dialysis solute clearance measurements. Facilities randomized to Usual Care will maintain their existing approaches to prescribing dialysis session duration. Participants will be followed for up to 3 years. The primary endpoint is mortality; major secondary endpoints are hospitalization rate and quality of life. Pragmatic features of the TiME Trial include 1) high generalizability due to non-restrictive eligibility criteria and broad representation of participating facilities, 2) implementation of the intervention by clinical care providers rather than by research personnel, and 3) reliance on data obtained through routine clinical care rather than through research activities.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Dialysis session of at least 4.25 hours


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialysis session of at least 4.25 hours<br>Dialysis facilities randomized to the Intervention arm will adopt an approach of recommending that all patients who are initiating treatment with maintenance hemodialysis have a treatment session duration of at least 4.25 hours. | Other: Dialysis session of at least 4.25 hours<br>* Facilities randomized to the Intervention arm will adopt the practice of recommending dialysis session durations of at least 4.25 hours for all patients initiating hemodialysis treatment regardless of body size or dialysis solute clearance measurements.<br>|
| No Intervention: Usual care<br>There will be no trial-driven approach to dialysis session duration in the Usual Care arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | The primary outcome for the TiME Trial is time to death. The trial hypothesis is that, in comparison with the Usual Care facilities, the risk of death will be lower in the facilities randomized to the Intervention group. | Throughout the 3 year (maximum) duration of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization rate | Hospitalization rate is a major secondary outcome of the TiME Trial. The trial hypothesis is that, in comparison with the Usual Care facilities, the rate of hospitalization will be lower in the facilities randomized to the Intervention group. | Throughout the 3 year (maximum) duration of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis, hemodialysis, pragmatic trial, end stage renal disease, randomized clinical trial