A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration (TiME)

University of Pennsylvania

Status: Terminated

Conditions: End Stage Renal Disease

Treatments: Other: Dialysis session of at least 4.25 hours

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02019225

817911

UH2AT007797 (U.S. NIH Grant/Contract)

UH3DK102384 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,053 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,053 participants in 2 patient groups

Dialysis session of at least 4.25 hours

Experimental group

Description:

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.

Treatment:

Other: Dialysis session of at least 4.25 hours

Usual care

No Intervention group

Description:

There will be no trial-driven approach to dialysis session duration in the Usual Care arm.