Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections

University of Kansas0 个研究点开始时间: 2009年7月最近更新: 2015年5月5日

适应症

试验速览

阶段: 不适用
状态: 撤回
发起方: University of Kansas
主要终点: Catheter site inspection

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
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

•Admission in the ICU at time of catheter insertion
•Indication for central venous catheter placement
•De novo catheter insertion in the subclavian or internal jugular veins

排除标准

•Anticipated catheter duration < 72 hours
•Planned guidewire exchange
•Documented bacteremia within 48 hours prior to catheter placement
•Extensive skin breakdown near the site of potential catheter placement
•Emergent line placement
•Screening labs with ANC < 500 or platelets < 50K
•Hypersensitivity to cyanoacrylates or formaldehyde
•Prior enrollment in study

结局指标

主要结局

Catheter site inspection

时间窗: Baseline, Daily

次要结局

未报告次要终点

研究者

发起方

University of Kansas

申办方类型

Other

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