Dressing: Comparison of 3-day and 7-day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-related Infection in ICU
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 8
- 主要终点
- Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings
研究概览
简要总结
The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.
详细描述
Central venous catheters (CVCs) are often required for the care of patient admitted to the intensive care unit (ICU), and are now indispensable in modern-day medical practice. In the United States, it is estimated that 15 million CVC days occur each year in the ICU , and that approximately 80,000 CVC-associated bloodstream infection (BSIs) occur each year [2]. Data from the NNIS system indicate that approximately 40% of the BSIs are associated with a CVC in the ICU. This definition, however, include CVC-related BSIs (CRBSIs) and primary BSIs. In other multicenter surveys, primary BSIs are the leading cause of BSIs (30-35%), followed by CRBSIs (20-30%), and BSIs originating from pneumonia (20%) .
The attributable mortality of CRBSIs remains debated. It ranges from no increase in mortality in some studies, up to an attributable mortality of 35% in others. In studies adjusting for severity of illness, attributable mortality ranged between 0 and 11.5%. The excess ICU length of stay is estimated 9-12 days.
The cost of CRBSIs is therefore substantial, and efforts are required to reduce the incidence of theses infections. Several publications suggested that multiple strategies should be implemented concomitantly. Besides the critical importance of staff education, technology brings new materials that could decrease the risk for CRBSI. Several studies have demonstrated that antimicrobial- or antiseptic-impregnated CVCs can decrease CRBSIs in the ICU setting. Furthermore, cost-benefit analysis have suggested that the use of impregnated CVCs was beneficial
The recent CDC Guidelines for the prevention of intravascular catheter-related infections recommend the use of antimicrobial- or antiseptic-impregnated CVCs in patients whose CVC is expected to remain in place for more than 5 days, and in ICUs where CRBSI rate remains above the benchmark rates, despite implementing a comprehensive strategy. This restricted recommended use is explained by the concern for emergence of resistance, the risk of adverse effects and the costs of these materials.
CRBSI rates in France could be lower than those observed in the United States. Data from two surveillance networks indicate that the rates of CRBSI range between 1 and 2 CRBSI per 1000 CVC days . Given these low rates, it is not clear that antimicrobial- or antiseptic-impregnated CVCs would be cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (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 older than 18 years
- •with at least a central venous catheter or an arterial catheter
- •whatever the first or subsequent CVC in a same patient
- •in any site of insertion (sub-clavian, jugular or femoral)
- •whatever le CVC is tunnelled or not
- •CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
- •CVC inserted under maximal barrier precautions
排除标准
- •pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
- •known allergy to chlorhexidine
- •CVC not inserted under maximal barrier precautions
- •Expected duration of CVC for less than 48 hours
- •CVC inserted under emergency conditions
结局指标
主要结局
Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings
时间窗: 48 hours
Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies
时间窗: 48 hours
次要结局
- catheter related septicemia(48 hours)
- cutaneous allergy(24 hours)
- cost(within the 60 days after catheter insertion)
