Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clinical outcome including mortality and technical failure
研究概览
简要总结
Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.
详细描述
To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, complications and life quality between the two groups will be investigated.
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
- •Age from 18 to 80, male or female.
- •End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
- •Maintenance peritoneal dialysis within 6 months after initiation of PD.
- •With informed consent.
排除标准
- •Acute renal injury.
- •Patients with an expected follow up less than 6 months sch as renal transplantation.
- •Transferred from hemodialysis or renal transplantation.
- •Residual renal function eGFR less than 1 ml/min.
- •HIV positive.
- •Cancer patients.
- •Unstable organ disease such as active tuberculosis and severe hepatitis. Patients with an expected follow up less than 48 weeks, such as planned kidney transplant.
- •Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.
研究组 & 干预措施
8 L dialysate
8 L peritoneal dialysis solution
干预措施: 8 L dialysate (Drug)
6 L dialysate
6 L peritoneal dialysis solution
干预措施: 6 L dialysate (Drug)
结局指标
主要结局
clinical outcome including mortality and technical failure
时间窗: 2 years
次要结局
- complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality(2 years)
研究者
Aiwu Lin
Vice Director, Department of Nephrology, Renji Hospital
Shanghai Jiao Tong University School of Medicine