NCT01101087已完成不适用
Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo
Centre Hospitalier Universitaire de Nīmes30 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 30
- 主要终点
- Occurence of bacterial peritonitis
研究概览
简要总结
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •18 years or older
- •Renal insufficiency, stage V (HAS 2007 classification)
- •Requires incident peritoneal dialysis
- •No signs of peritoneal infection on inclusion
- •signed consent
- •affiliated with a social security system
排除标准
- •Patient will have a renal transplant in the upcoming year following dialysis
- •Survival prognosis for one year is weak
- •allergy to citrate, (cyclo)-taurolidine, or heparin
- •patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
- •patient has a thrombopenia caused by heparin
- •impossible to inform the patient correctly
- •patient under guardianship
- •patient already included in another biomedical research protocol
- •no signed consent
- •no social security system
结局指标
主要结局
Occurence of bacterial peritonitis
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (30)
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