Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of a Standard Central Venous Catheter (CVC) in Comparison to a Coated CVC
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 4
- 主要终点
- Incidence of bloodstream infection
研究概览
简要总结
The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
详细描述
Central venous catheters are an essential part of patient management in the ICU (Intensive Care Unit). The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. It is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. Various types of antiseptic or antimicrobial vascular catheter coatings have been developed. Studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. The "Certofix protect" was developed by B.Braun to reduce the risk of catheter related infections. It is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with probable ICU stay
- •Patient's first or second catheter placement during actual hospital stay
- •Anticipated indwelling central venous catheter period >= 3 days (jugular vein, subclavian vein)
- •>= 18 years of age
- •Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible
排除标准
- •The catheter will not be placed in the femoral vein
- •Inflammation of the skin at the site of puncture prior to puncture
- •Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine)
- •Participation in another clinical trial
- •Emergency insertion of catheter in the field
结局指标
主要结局
Incidence of bloodstream infection
时间窗: during treatment
Incidence of catheter colonization
时间窗: after catheter removal
次要结局
- Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization(catheter removal)
- Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers(until discharge from ICU)