Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ultrafiltration volume
研究概览
简要总结
The investigators will carry out a prospective cross-over, pre-and post-controlled clinical study : 36 patients with continuous ambulatory peritoneal dialysis with high/high average transport will be recruited and treated with continuous ambulatory peritoneal dialysis and intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month respectively. The changes of peritoneal transport function and ultrafiltration volume before and after the two dialysis methods will be compared.
详细描述
- Inclusion Criteria
- Continuous ambulatory peritoneal dialysis for more than 3 months;
- The peritoneal transport function is high/high average transport (D/Pcr>0.65 at 4 hours in the peritoneal balance test);
- Sign the informed consent form voluntarily.
- Exclusion Criteria
- Patients with peritonitis in the past 3 months;
- Patients with acute complications such as cardiovascular events, pulmonary infection and gastrointestinal bleeding in the past 3 months;
- The doctor judged that it was not suitable for the patients in this study for other reasons.
- Treatment plan
The patients will be divided into two groups randomly: group A carry on continuous ambulatory peritoneal dialysis (the original dialysis plan) for 1 month, and then changed to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine，the concentration and dosage of dialysate are consistent with the original plan) for 1 month; Group B carry on intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine，the concentration and dosage of dialysate are consistent with the original plan) for 1 month, and then change to continuous ambulatory peritoneal dialysis (original dialysis plan) for 1 month. 4. Observation indicators
Main observation indicators:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous ambulatory peritoneal dialysis for more than 3 months;
- •The peritoneal transport function is high/high average transport (D/Pcr>0.65 at 4 hours in the peritoneal balance test);
- •Sign the informed consent form voluntarily.
排除标准
- •Patients with peritonitis in the past 3 months;
- •Patients with acute complications such as cardiovascular events, pulmonary infection and gastrointestinal bleeding in the past 3 months;
- •The doctor judged that it was not suitable for the patients in this study for other reasons.
研究组 & 干预措施
Group A
group A carry on continuous ambulatory peritoneal dialysis (the original dialysis method) for 1 month, and then changed to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month
干预措施: peritoneal rest (Combination Product)
Group B
Group B carry on intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month, and then change to continuous ambulatory peritoneal dialysis (original dialysis method) for 1 month.
干预措施: peritoneal rest (Combination Product)
结局指标
主要结局
ultrafiltration volume
时间窗: 1 month
represented by 4-hour ultrafiltration volume in the standard peritoneal balance test
peritoneal transport rate
时间窗: 1 month
represented by 4-hour D/Pcr in the standard peritoneal balance test
次要结局
未报告次要终点
研究者
Wu Bei
Principal Investigator
Peking University People's Hospital