Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Adequacy of dialysis
研究概览
简要总结
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.
详细描述
Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.
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
- •The duration of PD is more than 1 month.
- •The age is range from 18 to 80 years old.
- •The patient can be treated with regular PD in home.
- •The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
- •The patient can be visited regularly.
- •The patient must be freely given informed consent
排除标准
- •Peritonitis was happened within 1 month
- •The KT/V<1.7
- •Infections in the exit or tunnel
- •With tumors.
- •With low transport of peritoneum.
- •With mental and behavior disorders.
- •With acute renal failure
- •Hemodialysis meanwhile
- •With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
- •Attending other clinical trails
- •Refused to give informed consent Exit criteria
- •（1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
结局指标
主要结局
Adequacy of dialysis
时间窗: up to 8 weeks
kt/v
次要结局
- Residual kidney function(up to 6 months)
- Peritoneal function(up to 6 months)
研究者
Yanhong Deng
Sun Yat-sen University
Sun Yat-sen University