Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 5
- 主要终点
- Major catheter related infection
研究概览
简要总结
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.
This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.
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
- None
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
- •≥ 18 year-old
- •Expected duration of ICU stay ≥ 48 hours
- •Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.
排除标准
- •Patient with history of allergy to any of the antiseptic agent studied
- •Expected survival < 48 hours
- •Catheter inserted outside the ICU or in emergency without respect of preventive measures.
- •Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
- •Pregnant woman or breast-feeding mother
研究组 & 干预措施
PVI paint
5% alcoholic povidone iodine paint
干预措施: skin disinfection prior catheter insertion (Procedure)
PVI scrub and paint
detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint
干预措施: skin disinfection prior catheter insertion (Procedure)
Chlorhexidine paint
2% alcoholic chlorhexidine paint
干预措施: skin disinfection prior catheter insertion (Procedure)
chlorhexidine scrub and paint
Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint
干预措施: skin disinfection prior catheter insertion (Procedure)
结局指标
主要结局
Major catheter related infection
次要结局
- Skin allergy and anaphylactic shock
- Mortality due to catheter infection
- Catheter related bacteremia
- Catheter colonization
- Colonization insertion site
- Prolongation hospitalization due to catheter infection
- Costs
