HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Clearance rate of uremic toxins
研究概览
简要总结
This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (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
- •Age≥18, male or female
- •Maintenance hemodialysis duration>3 months
- •Regular hemodialysis,3 times a week,4 hours per session
- •Vascular access unlimited
- •iPTH≥300pg/ml
- •Sign the written informed consent
排除标准
- •Allergic to dialysis equipment
- •PLT<60×10^9/L
- •Blood flow<200ml/min
- •Serum albumin<30g/L
- •iPTH>800pg/ml
- •Hemodiafiltration
- •Coagulation disorder, severe bleeding tendency, with active bleeding
- •Severe hypotension, severe cardiopulmonary insufficiency
- •Under other drug trial
- •Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
研究组 & 干预措施
low flux hemodialysis
low flux hemodialysis alone, 3 times a week, 4 hours per session
干预措施: low flux dialyzer (Device)
high flux hemodialysis
high flux hemodialysis alone, 3 times a week, 4 hours per session
干预措施: high flux dialyzer (Device)
low flux hemodialysis + hemoperfusion
low flux hemodialysis 2times a week and the HD+HP once a week
干预措施: low flux dialyzer (Device)
low flux hemodialysis + hemoperfusion
low flux hemodialysis 2times a week and the HD+HP once a week
干预措施: hemoperfusion apparatus (Device)
high flux hemodialysis + hemoperfusion
high flux hemodialysis 2times a week and the HD+HP once a week
干预措施: hemoperfusion apparatus (Device)
high flux hemodialysis + hemoperfusion
high flux hemodialysis 2times a week and the HD+HP once a week
干预措施: high flux dialyzer (Device)
结局指标
主要结局
Clearance rate of uremic toxins
时间窗: 0,3,6,12 months
次要结局
- Evaluation of quality of life(0,3,6,12 months)
研究者
Xiangmei Chen
Professor,Chief physician,Academician of Chinese Academy of Engineering,Chinese PLA General Hospital
Chinese PLA General Hospital