Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adequacy of dialysis (kt/v)
研究概览
简要总结
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.
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 most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 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 (kt/v)
时间窗: up to 8 weeks
kt/v
次要结局
- Residual kidney function (Residual kidney kt/v)(up to 6 months)
- Peritoneal function (Peritoneal equilibration test)(up to 6 months)
研究者
Yanhong Deng
The Sixth Affiliated Hospital of Sun Yat-Sen University
Sun Yat-sen University