Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 3
- 主要终点
- Incidence of catheter dysfunction that requires intervention
研究概览
简要总结
This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.
详细描述
The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •requires dialysis catheter insertion for maintenance peritoneal dialysis
- •aged 18 or older
- •willingness to give written consent and comply with the study protocol
排除标准
- •known contraindication to peritoneal dialysis
- •participation in another interventional study within last 30 days of randomization
- •history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures
结局指标
主要结局
Incidence of catheter dysfunction that requires intervention
时间窗: One year
Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically
次要结局
- Time to catheter dysfunction requiring intervention(One year)
- Peritoneal dialysis catheter survival(One year)
- Dialysis catheter migration with dysfunction(One year)
- Risk of peritonitis(One year)
- Technique failure(One year)
- Infusion pain(One month)
研究者
Chow Kai Ming
Dr
Chinese University of Hong Kong