Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 299
- 主要终点
- Time to first occurrence of an event in the primary composite outcome
研究概览
简要总结
This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.
详细描述
RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations.
Dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. All other care will be according to standard local practices as determined by the site.
Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients.
It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to first occurrence of an event in the primary composite outcome
时间窗: Through to study completion (estimated to occur after an average of 5 years follow up)
Primary outcome is a composite of major cardiovascular events (hospitalised acute myocardial infarction, hospitalised stroke) and all-cause death. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.
次要结局
- Time to first occurrence of each of the individual components of the composite outcomes.(Through to study completion (estimated to occur after an average of 5 years follow up))
- Time to first occurrence of an event in the secondary composite outcome(Through to study completion (estimated to occur after an average of 5 years follow up))