A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration (TiME)
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|ClinicalTrials.gov Identifier: NCT02019225|
Recruitment Status : Terminated (Insufficient separation in session duration between randomized treatment groups)
First Posted : December 24, 2013
Last Update Posted : June 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Other: Dialysis session of at least 4.25 hours||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7053 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial|
|Actual Study Start Date :||December 18, 2013|
|Actual Primary Completion Date :||January 31, 2017|
|Actual Study Completion Date :||April 30, 2017|
Experimental: 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.
Other: Dialysis session of at least 4.25 hours
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.
No Intervention: Usual care
There will be no trial-driven approach to dialysis session duration in the Usual Care arm.
- All cause mortality [ Time Frame: 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.
- Hospitalization rate [ Time Frame: 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.
- Quality of Life [ Time Frame: Annually throughout the duration of follow-up. Patients will be followed up to 3 years. ]The Health Related Quality of Life (HRQOL) questionnaire used for the TiME Trial will be the KDQOL™36, a kidney disease-specific instrument.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019225
|United States, Massachusetts|
|Fresenius Medical Care North America|
|Waltham, Massachusetts, United States, 02451|
|United States, Minnesota|
|DaVita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Laura M Dember, MD||University of Pennsylvania|