Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,088
- 试验地点
- 2
- 主要终点
- The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
研究概览
简要总结
We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.
详细描述
At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.
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
- •patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).
排除标准
- •patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.
结局指标
主要结局
The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
时间窗: 2 years
The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization
次要结局
- Clinical Sepsis Episodes/Per 1000 Catheter Days(2 years)