A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

End Stage Renal Disease Clinical Trial

— TiME  

Official title:

Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02019225
• Other study ID #: 817911
• Secondary ID: UH3DK102384UH2AT
• Status: Terminated
• Phase: N/A
• Start date: December 18, 2013
• Est. completion date: April 30, 2017

Study information

• Verified date: June 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7053
• Est. completion date: April 30, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Fresenius Medical Care North America	Waltham	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	Davita Clinical Research, Fresenius Medical Care North America, National Center for Complementary and Integrative Health (NCCIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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