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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Fresenius Medical Care North America
Davita Clinical Research
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: Dialysis session of at least 4.25 hours Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7053 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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


Locations
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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)
National Institutes of Health (NIH)
Fresenius Medical Care North America
Davita Clinical Research
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Laura M Dember, MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Keywords provided by University of Pennsylvania:
dialysis
hemodialysis
pragmatic trial
end stage renal disease
randomized clinical trial
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency