A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- death
研究概览
简要总结
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Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
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Design: prospective,randomized,controlled,single center study
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Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
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Objects: incident and prevalent patients with overhydration status.
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anticipated cases:240
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arms: all the patients are randomized into two arms.(BIA group/clinical group)
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observational time:12 months
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Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
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 who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
- •18 Years and older;
- •ratio extracellular water (ECW)/total body water(TBW)≧0.4;
- •signed the informed consent
排除标准
- •patients who have mental graft;
- •amputation;
- •patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
- •patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
- •Patients who have acute complications within 30 days prior to study enrollment;
- •patients whose life expectancy is within 6 months;
- •patients who are pregnant;
- •patients who are unable to give consent.
研究组 & 干预措施
bioimpedance monitoring group
patients whose fluid status will be monitored and guided by bioimpedance analysis
干预措施: bioimpedance monitoring (Device)
clinical monitoring group
patients whose fluid status will be monitored and guided by clinical experience
干预措施: clinical monitoring (Other)
结局指标
主要结局
death
时间窗: 12 months
all cause mortality;cardiovascular related mortality
次要结局
- cardiovascular events(12 months)
- clinical adverse events(12 months)
- technique failure(12 months)
- residual renal function(12 months)
研究者
Xue Qing Yu
Director, Institute of Nephrology, Sun Yat-sen University
Sun Yat-sen University