Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications. The main questions it aims to answer are:
Does bioimpedance-guided fluid management decrease major cardiovascular events? Does bioimpedance-guided fluid management decrease other hemodialysis complications?
Participants will:
Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group
详细描述
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events (MACE), symptoms during hemodialysis, or other important outcomes such as vascular access patency, fluid overload admissions, etc. in maintenance hemodialysis patients. The main questions it aims to answer are:
Hypothesis 1: bioimpedance-guided fluid management decreases MACE Hypothesis 2: bioimpedance-guided fluid management decreases intradialytic hypotension, cramps and fatigue Hypothesis 3: bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis
Participants in the control group will decide their target weight according to physician's suggestion and the patient's preference, according to symptoms that are thought related to fluid status aberrancy (for example, edema, crackles for fluid overload, and cramps, intradialytic hypotension, fatigue for fluid insufficiency, given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5% of previous weight)
Participants in the active (bioimpedance) group will adjust their dry weight as those in the control group, if symptoms of fluid status aberrancy present. However, if no symptoms occur, they will receive adjustment according to measurements by bioimpedance analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Has received hemodialysis >= 3 months
- •Has at least 1 pair of intact same-side upper extremity and lower extremity
排除标准
- •With a cardiac pacemaker
- •With metallic implants that may interfere with measurements (cardiac stents acceptable)
研究组 & 干预措施
Bioimpedance
Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
干预措施: Bioimpedance (Device)
Control
Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators
干预措施: Control (Device)
结局指标
主要结局
Major adverse cardiovascular events
时间窗: From first bioimpedance analysis done to 1 year later
A composite of myocardial infarction, stroke and all-cause mortality
次要结局
- The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps(From first bioimpedance analysis done to 1 year later)
- The number of hemodialysis sessions with pitting edema(From first bioimpedance analysis done to 1 year later)
- The number of hemodialysis sessions with intradialytic hypotension(From first bioimpedance analysis done to 1 year later)
- The number of hemodialysis sessions with lung edema(From first bioimpedance analysis done to 1 year later)
- The number of hemodialysis sessions with non-function of arteriovenous shunt(From first bioimpedance analysis done to 1 year later)
研究者
Han-ming Kuo
Director, Division of Nephrology
Cishan Hospital, Ministry of Health and Welfare