Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Adverse reactions associated with the use of dialysis machines
研究概览
简要总结
An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.
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 —（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
- •Sign the written informed consent
排除标准
- •Acute kidney injury
- •Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
- •Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
- •Pregnancy or lactation
- •Under other drug trial
- •Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
- •Can not be treated in accordance with the research program
研究组 & 干预措施
Group of domestic hemodialysis machine
干预措施: domestic hemodialysis machine (Device)
Group of imported hemodialysis machine
干预措施: imported hemodialysis machine (Device)
结局指标
主要结局
Adverse reactions associated with the use of dialysis machines
时间窗: 0 to 3 months
次要结局
- The results of bacterial culture of dialysate(0,1,2,3 months)
- Clearance rate of uremic toxins(0,1,2,3 months)
- The results of endotoxin level of dialysate(0,1,2,3 months)
研究者
Xiangmei Chen
Professor,Chief physician,Academician of Chinese Academy of Engineering
Chinese PLA General Hospital