End Stage Renal Disease
Conditions
Keywords
dialysis, hemodialysis, pragmatic trial, end stage renal disease, randomized clinical trial
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.
Interventions
OTHERDialysis 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Fresenius Medical Care North America
Davita Clinical Research
National Center for Complementary and Integrative Health (NCCIH)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | Throughout the 3 year (maximum) duration of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization rate | Throughout the 3 year (maximum) duration of follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Annually throughout the duration of follow-up. Patients will be followed up to 3 years. | The Health Related Quality of Life (HRQOL) questionnaire used for the TiME Trial will be the KDQOL™36, a kidney disease-specific instrument. |
Countries
United States
Outcome results
None listed