A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | December 18, 2013 |
| End Date: | April 30, 2017 |
Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial
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.
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.
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.
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.
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.
We found this trial at
2
sites
825 South 8th Street
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
888-345-2567
Principal Investigator: Steven Brunelli, MD, MSCE
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Waltham, Massachusetts 02451
Principal Investigator: Thadhani Ravi, MD, MPH
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