Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- patient mortality
研究概览
简要总结
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.
详细描述
Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older but no older than 80 years.
- •who had been on chronic peritoneal dialysis for more than 3 months.
- •All of them have signed the informed consent.
排除标准
- •were expected to stop PD treatment in 6 months;
- •were amputees;
- •had a cardiac pacemaker or metallic implants;
- •had peritonitis one month before recruitment;
- •treated together with hemodialysis;
- •were during pregnancy or lactation;
- •were positive with HIV;
- •had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.
结局指标
主要结局
patient mortality
时间窗: 96 weeks
different rates of all-cause patient mortality and cardiovascular mortality
technique failure
时间窗: 96 weeks
different incidence of technique failure during peritoneal dialysis treatment
The incidence of cardiovascular events
时间窗: 96 weeks
different incidence of cardiovascular diseases
volume status
时间窗: 96 weeks
change in overhydration(OH) value
次要结局
- residual renal function(96 weeks)
- peritoneal function(96 weeks)
- blood pressure(96 weeks)
- heart function(96 weeks)