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临床试验/NCT03309137
NCT03309137已完成不适用

CHG-Lock™ Device for Bacteremia Prevention in Cardiac Surgical Intensive Care Unit Patients: An Open Label Randomized Feasibility Pilot Study

Alison Fox-Robichaud2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月19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
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:

  1. Steril-flow® (CHG-Lock™) device OR
  2. 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

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

发起方
Alison Fox-Robichaud
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alison Fox-Robichaud

Professor McMaster University and Director of Medical Education at HHS

Hamilton Health Sciences Corporation

研究点 (2)

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