A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

NCT02019225 | Terminated DMC

• 3 other identifiers: 817911UH3DK102384UH2AT007797
• Study Type: interventional
• Target: 7,053
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Keywords

dialysis; hemodialysis; pragmatic trial; end stage renal disease; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospitalization rate

  Throughout the 3 year (maximum) duration of follow-up

Other Outcomes (1)

• Quality of Life

  Annually throughout the duration of follow-up. Patients will be followed up to 3 years.

Study Arms (2)

Dialysis session of at least 4.25 hours

EXPERIMENTAL

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

Usual care

NO INTERVENTION

There will be no trial-driven approach to dialysis session duration in the Usual Care arm.

Interventions

Dialysis session of at least 4.25 hours OTHER

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.

Dialysis session of at least 4.25 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Initiation of maintenance dialysis within the past 120 days.
• Treatment with maintenance dialysis in a participating facility.
• Age ≥18 years.

You may not qualify if:

• Unwillingness to participate.
• Inability to provide consent for dialysis care.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator
• Fresenius Medical Care North America: collaborator
• Davita Clinical Research: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Fresenius Medical Care North America

Waltham, Massachusetts, 02451, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

• 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.

  PMID: 26772801 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura M Dember, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 24, 2013
• Study Start: December 18, 2013
• Primary Completion: January 31, 2017
• Study Completion: April 30, 2017
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

US (2)