The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- survival rate
研究概览
简要总结
This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.
详细描述
This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.
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
- 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
- •Patients with end stage renal diseases
- •Dialysis mode: CAPD
- •Dialysis duration:≥30 days and ≤6 months
- •Be capable of implementing home dialysis
- •Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min
- •Sign the written informed consent
排除标准
- •Acute renal failure
- •Planing to receive kidney transplantation in 2 years
- •Hemodialysis
- •Exit site infection or tunnel infection
- •Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid;
- •Anti-HIV positive
- •Allergic to components of dialysate
- •Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb<80g/L）,malnutrition（Serum Alb<28g/L）,refractory hypertension
- •Identified peritoneal high transportation by peritoneal equilibration test (PET)
- •Extreme body shape (height> 185cm or height <145cm), obesity (BMI ≥ 33kg/m2)
- •Poor compliance
- •Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial
- •Has a history of alcoholism and drug abuse (defined as illegal drugs)
- •Any circumstances when patients are believed unsuitable for this trial
研究组 & 干预措施
Huaren peritoneal dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
干预措施: Huaren Peritoneal Dialysate (Drug)
Baxter Peritoneal Dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d
干预措施: Baxter Peritoneal Dialysate (Drug)
结局指标
主要结局
survival rate
时间窗: 1,2,3,4,5 years
次要结局
- dropout rate(1,2,3,4,5 years)
- increments of dialysis dose(1,2,3,4,5 years)
- cardiovascular events(1,2,3,4,5 years)
- nutritional status(1,2,3,4,5 years)
- quality of life(SF-36)(1,2,3,4,5 years)
- PD technique survival rate(1,2,3,4,5 years)
- estimated glomerular filtration rate decline(1,2,3,4,5 years)
- medical costs(1,2,3,4,5 years)
研究者
Chen Xiangmei
Professor, Chief physician, Academician of Chinese Academy of Engineering
Chinese PLA General Hospital