Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
A Prospective, Randomized Study to Evaluate the Risks Related to Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
This project proposes to answer the following questions:
To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to determine the regimen that will minimize infectious risk in children with burns.
The scientific knowledge to be acquired through this project is of likely benefit to the care of children with orthopaedic problems, spinal cord injuries or burns as follows:
The intention is to improve the outcomes in burned children by minimizing one of the most frequent causes of infection in the burn intensive care unit, those from central venous catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease costs, and decrease mortality in burned children
研究概览
详细说明
Aim: To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to create a system that will minimize infectious risk in this patient population.
Hypothesis: A strategy of routine catheter changes without guidewire exchange will result in no more infections and a decreased risk of mechanical complications over frequent guidewire exchange or frequent new-site replacement.
Background: Reviews of burned children have implied that it is safe to change CVCs on a weekly basis, either by new site insertion or by wire exchange. In non-burn populations the routine use of wire exchange may increase infectious risk. Laboratory investigations have shown that the longer catheters are in place, the more often they are colonized with bacteria; this translates to an increase in catheter infection and patient sepsis. Centers for Disease Control recommendations note that catheters should not be routinely changed. The burn literature has disagreed with this concept, proffering that the change in microbial milieu from the burn wound increases infection risk, and national data indicates that burn units have three to four times higher rates of catheter related bloodstream infections than do other intensive care units. There is a trend in the existent retrospective data that using wires to change central venous catheters increases the risk of infection: CVCs changed to a new site have an infection rate of 16.6 per 1000 catheter days, whereas those changed by means of a wire have a rate of 25.2 per 1000 catheter days.
Methods: Patients will be randomized to three intervention groups: a frequent (6 days) moving of catheters to new sites; an alternating schedule of wire exchanges and new sites (every 6 and 12 days); and a less frequent moving of catheters to new sites (12 days) without wire exchange. This project requires enough patients to show a difference between three intervention groups. A significant decrease in infection rate would be from the current 20 infections per 1000 catheter days to approximately 15 per 1000 catheter days. This would require a minimum of 1000 catheter days per group.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Sacramento、California、美国、95817
- 招聘中
- Shriners Hospital for Children Northern California
-
接触:
- Michael S O'Mara, MD
- 电话号码:916-452-2050
- 邮箱:momara@shrinenet.org
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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
Inclusion Criteria:
- Burn patient with central venous catheter
Exclusion Criteria:
- none
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:1
Change every 6 days, rewire every 6 days
|
Changeing CVCs on a regular basis to decrease infection rate.
|
其他:2
New site every 6 days
|
Changeing CVCs on a regular basis to decrease infection rate.
|
其他:3
New site every 12 days
|
Changeing CVCs on a regular basis to decrease infection rate.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
CVC related blood stream infections.
大体时间:patient discharge/CVC removal
|
patient discharge/CVC removal
|
次要结果测量
结果测量 |
大体时间 |
---|---|
CVC mechanical complications
大体时间:patient discharge/CVC removal
|
patient discharge/CVC removal
|
合作者和调查者
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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