Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7,053
- 试验地点
- 4
- 主要终点
- All cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Unwillingness to participate.
- •Inability to provide consent for dialysis care.
研究组 & 干预措施
Dialysis session of at least 4.25 hours
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.
干预措施: Dialysis session of at least 4.25 hours (Other)
Usual care
There will be no trial-driven approach to dialysis session duration in the Usual Care arm.
结局指标
主要结局
All cause mortality
时间窗: 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.
次要结局
- Hospitalization rate(Throughout the 3 year (maximum) duration of follow-up)