Clinical trial NCT02019225: A Cluster-randomized, Pragmatic Trial of Hemodialysis Session Duration
Official title: Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: dialysis
hemodialysis
pragmatic trial
end stage renal disease
randomized clinical trial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
name: Fresenius Medical Care North America
name: Davita Clinical Research
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-12-24
Enrollment: 7053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: All cause mortality
timeFrame: Throughout the 3 year (maximum) duration of follow-up
Secondary outcomes:
measure: Hospitalization rate
timeFrame: Throughout the 3 year (maximum) duration of follow-up
Other outcomes:
measure: Quality of Life
timeFrame: Annually throughout the duration of follow-up. Patients will be followed up to 3 years.
Locations:
city: Waltham
country: United States
facility: Fresenius Medical Care North America
state: Massachusetts
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: University of Pennsylvania
name: Laura M Dember, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.