CHG-Lock™ Device for Bacteremia Prevention in Cardiac Surgical Intensive Care Unit Patients: An Open Label Randomized Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Compliance with the protocol
研究概览
简要总结
Intravenous catheters are often placed in large (central) veins in critically ill patients to provide special medications or frequent blood sampling. The body reacts to the presence of foreign material by forming a biofilm on the surface within the catheter. Either due to the patients condition or to emergency access to these intravenous lines can become infected with bacteria and reside within the biofilm. When bacteria is grown from these lines it is referred to as: a central line infection. A medical device company (ICU Medical) has obtained the rights to a device that delivers a controlled amount of a cleaning material called chlorhexidine into the catheter to prevent bacterial growth when not in use. Chlorhexidine is the standard cleaning material used on patients when cleaning the skin for surgical procedures or central intravenous catheter insertion. In laboratory tests and animal studies that chlorhexidine inhibits the growth of bacteria and fungi that often cause central line infections. This study will the first assessment in patients with central lines.
详细描述
Randomization Randomization will be determined using an online random number generator. "www.randomize.net". The research coordinator will randomize the patients and provide bedside staff with the devices when appropriate.
Intervention
Eligible patients that have provided informed consent will be randomized to receive:
- Steril-flow® (CHG-Lock™) device OR
- Usual care
Test Protocol
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-100 year old adult patients admitted to the ICU;
- •Same-day admit to ICU;
- •Post-op patient with central lines in situ (PICC, multi-lumen, side arm of introducer catheters or temporary dialysis lines), AND;
- •Expected to have at least 1 central line in situ for more than 72 hrs.
排除标准
- •>24hrs post-admittance to ICU
- •Hopeless prognosis
- •Currently admitted with known infection or suspicion of infection (i.e. known endocarditis or other infections).
- •Chronic indwelling central venous catheters present
- •Patients with known allergies to chlorhexidine
结局指标
主要结局
Compliance with the protocol
时间窗: Through study completion, an average of 14 days
The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking.
次要结局
- Bacteremia(Through study completion, an average of 14 days)
- Bacteria colonization of central line(Through study completion, an average of 14 days)
研究者
Alison Fox-Robichaud
Professor McMaster University and Director of Medical Education at HHS
Hamilton Health Sciences Corporation
