A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

Not Applicable

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Other: Dialysis session of at least 4.25 hours

• Registration Number: NCT02019225
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-12-17
• Study Start: 2013-12-18
• Study First Posted: 2013-12-24
• Primary Completion: 2017-01-31
• Study Completion: 2017-04-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7053

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.

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Exclusion Criteria

• Unwillingness to participate.
• Inability to provide consent for dialysis care.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialysis session of at least 4.25 hours	Dialysis session of at least 4.25 hours	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality	Throughout the 3 year (maximum) duration of follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalization rate	Throughout the 3 year (maximum) duration of follow-up	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.

Trial Locations

Locations (2)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

Fresenius Medical Care North America; 🇺🇸 Waltham, Massachusetts, United States