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

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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: Dialysis session of at least 4.25 hours

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.

• Study Type: Interventional
• Enrollment (Actual): 7053
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Fresenius Medical Care North America
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	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.	Throughout the 3 year (maximum) duration of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rate	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.	Throughout the 3 year (maximum) duration of follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The Health Related Quality of Life (HRQOL) questionnaire used for the TiME Trial will be the KDQOL™36, a kidney disease-specific instrument.	Annually throughout the duration of follow-up. Patients will be followed up to 3 years.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH); Fresenius Medical Care North America; Davita Clinical Research
• Investigators: Principal Investigator: Laura M Dember, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2013
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: dialysis; hemodialysis; pragmatic trial; randomized clinical trial; end stage renal disease
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 817911; UH3DK102384 (U.S. NIH Grant/Contract); UH2AT007797 (U.S. NIH Grant/Contract)