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A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration

NCT02019225 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7053

Last updated 2019-06-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fresenius Medical Care North America

    collaborator INDUSTRY

  • Davita Clinical Research

    collaborator INDUSTRY

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Laura M Dember, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-18
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019225 on ClinicalTrials.gov