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A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration (TiME)
This study has been terminated.
(Insufficient separation in session duration between randomized treatment groups)
Sponsor:
University of Pennsylvania
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH Common Fund
Fresenius Medical Care North America
DaVita
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02019225
First received: October 30, 2013
Last updated: June 28, 2017
Last verified: June 2017
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Purpose
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 | Intervention |
|---|---|
| End Stage Renal Disease | Other: Dialysis session of at least 4.25 hours |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
Other Outcome Measures:
- 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.
| Enrollment: | 7053 |
| Actual Study Start Date: | December 18, 2013 |
| Estimated Study Completion Date: | December 2018 |
| Primary Completion Date: | January 31, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02019225
Please refer to this study by its ClinicalTrials.gov identifier: NCT02019225
Locations
| United States, Massachusetts | |
| Fresenius Medical Care North America | |
| Waltham, Massachusetts, United States, 02451 | |
| United States, Minnesota | |
| DaVita Clinical Research | |
| Minneapolis, Minnesota, United States, 55404 | |
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH Common Fund
Fresenius Medical Care North America
DaVita
Investigators
| Principal Investigator: | Laura M Dember, MD | University of Pennsylvania |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT02019225 History of Changes |
| Other Study ID Numbers: |
817911 UH3DK102384 ( U.S. NIH Grant/Contract ) UH2AT007797 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 30, 2013 |
| Last Updated: | June 28, 2017 |
Keywords provided by University of Pennsylvania:
|
dialysis hemodialysis pragmatic trial end stage renal disease randomized clinical trial |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on July 17, 2017