Comparison of Three Strategies for Changing of Central Venous Catheters in Patients With Serious Burns for the Prevention of Catheter-associated Bacteremia: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,120
- 试验地点
- 4
- 主要终点
- Accumulative Incidence rate of catheter-related bacteremia
研究概览
简要总结
The aim of this project is to answer the following questions:
To determine the incidence of catheter related bacteremia (CRB) with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia.
To determine the incidence rate of catheter colonization in adult patients with major burns.
The scientific knowledge to be acquired through this project is of likely benefit to the care of critically ill patients with burns injury as follows:
The intention is to improve the outcomes in critically ill patients 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.
详细描述
Aim: To determine the incidence of catheter-related bacteremia (CRB) with three primary schedules of central venous catheter exchange in adult critically ill patients with major burn injury.
Hypothesis: A strategy of catheter exchange according with clinical criteria will result in no more CRB compared with a routine catheter changes without guidewire exchange strategy or frequent guidewire exchange or frequent new-site replacement.
Background: The intravenous catheter-related bacteremia (ICRB) is a nosocomial infection affecting patients admitted to intensive care and that leads to increased morbidity. Accumulative incidence rates of ICRB are 5.5 infections per 1000 catheters-day. Several strategies have been proposed to decrease of the rate of ICRB in critically ill patients. However, there is not agreement to recommend a replacement pattern of central venous catheters in adult critically ill patients with major burns as a strategy for the reduction in intravenous catheter-associated bacteremia.
Objectives. To compare three strategies of replacement from central venous catheters for the prevention of ICRB. Find out the risk of mechanical complications associated with each strategy of central venous catheter replacement.
Method. Randomized, multicenter clinical trial, single blind to compare three strategies for intravenous catheter replacement in patients with major burns: a scheduled wire-guided strategy every six days: second, a scheduled strategy of replacement every six days in a different punction and third, a re-change strategy guided by clinical criteria for suspicion of catheter-associated infection. Primary outcome: catheter colonization rate and rate of intravenous catheter-associated bacteremia. Secondarily, we calculate the incidence rate of colonization of central venous catheter and finally we will analyze the associated complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adults (> 18 years old) admitted in a Critical Care Burn Center with a total body surface area (TBSA) greater than 20% and/or smoke inhalation injury.
排除标准
- •Adults admitted in a Critical Care Burn Center with a Do-Not-Resuscitate (DNAR) order due to severity of injuries.
结局指标
主要结局
Accumulative Incidence rate of catheter-related bacteremia
时间窗: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)
次要结局
- Accumulative incidence rate of catheter colonization(participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011))
- Mechanical complications of catheter insertion(during the procedure of central catheter insertion)
研究者
Oscar Penuelas, MD
MD, Attending of Critica Care Department and Burns Center, Hospital Universitario de Getafe
Hospital Universitario Getafe