Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
研究概览
简要总结
The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.
详细描述
- The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
- The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.
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
- •incident CAPD patients aged 18 to 80 years
- •GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day
排除标准
- •have a history of maintenance hemodialysis or renal transplantation
- •anticipated life expectancy less than 6 months
- •with active malignancy, acute infection, significant heart failure or in other severe conditions
- •unable to give informed consent
研究组 & 干预措施
Three 2-liter exchanges group
A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
干预措施: Three 2-liter exchanges daily CAPD (Other)
Four 2-liter exchanges group
A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
干预措施: Four 2-liter exchanges daily CAPD (Other)
结局指标
主要结局
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
时间窗: Up to 24 months after CAPD initiation
GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol \< 100 ml/day for more than a month.
次要结局
- Episodes of peritonitis(Up to 24 months after CAPD initiation)
- Number of participants having technique failure refering to switching to maintenance hemodialyisis(Up to 24 months after CAPD initiation.)
- Number of participants died(Up to 24 months after CAPD initiation)
研究者
Aiwu Lin
MD, PhD
Shanghai Jiao Tong University School of Medicine