Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections
Vascular access via central venous lines (CVL) is essential to the care of many patients in the intensive care setting. While the value of these lines for the management of critically ill patients is generally accepted, the potential for line-associated blood stream infection is a known complication of the use of this intervention.
Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens.
The purpose of this study is to evaluate the effectiveness of daily treatment of the catheter lumen with ethanol to prevent central line associated blood stream infections (CLABSI). The hypothesis is that this treatment will reduce the incidence of CLABSI compared to maintenance of the lines with normal saline alone.
研究概览
详细说明
Blood stream infections are an important complication of the use of central venous lines (CVLs) and result in increased morbidity, mortality, and cost. Blood stream infections related to CVLs may be the result of migration of skin organisms along the catheter tract or introduction of organisms into the lumen of the catheter. The extraluminal route of infection appears to be most common early after catheter insertion while the frequency of infection acquired by the intraluminal route appears to increase the longer the catheter is in place. Meticulous attention to best practices for insertion and the subsequent care of the insertion site reduces infection by the extraluminal route. Adherence to good technique for entering the line may similarly reduce infection by the intraluminal route.
Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens; including the bacteria and fungi which most commonly infect CVLs. The mechanism of the antimicrobial activity of ethanol is attributed to the ability to denature proteins and induced resistance to the effect of ethanol has not been reported. These features suggest that ethanol-lock is a promising approach to the prevention of acquisition of central line associated blood stream infections by the intraluminal route.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Virginia
-
Charlottesville、Virginia、美国、22903
- 招聘中
- University of Virginia
-
接触：
- Donna Weakley-Marion
- 电话号码：434-924-2169
- 邮箱：dw4c@virginia.edu
-
首席研究员：
- Ron Turner, MD
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Although this study is done in the patient-care setting, patients are not the subject of the study. The outcome of interest involves the development of CLABSI in patients but the intervention is directed at the patient's central lines rather than the patient. There are no inclusion or exclusion criteria; the determination of the line care regimen will be determined by the bed assignment rather than any characteristics of the patient occupying the bed.
All central line will be included in this study. Use of ethanol will be suspended whenever the usage of the line precludes instillation of ethanol with a dwell time of al least one hour.
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：saline lock maintenance
Standard saline lock maintenance
|
Standard saline procedure will be utilized.
|
|
实验性的：ethanol maintenance
Instillation of 70% pharmaceutical grade ethanol solution into the central line in a volume calculated to fill the catheter lumen and hub.
|
70% pharmaceutical grade ethanol will be instilled in the line in a volume calculated to fill the lumen and the hub.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of beds using ethanol treatment
大体时间：12 months
|
The primary endpoint of the study will be the effectiveness of ethanol for prevention of CLABSI compared to routine care.
This will be assessed at the end of the study (12 months)by comparing the number of beds being maintained by each regimine to determine if the distribution of line maintenance regimines is non-random in favor of either ethanol lock or saline maintenance.
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Ron Turner, MD、University of Virginia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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