Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 12
- 主要终点
- Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
研究概览
简要总结
The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection
详细描述
Open-label, multicenter, randomized, controlled trial. This study will be conducted in patients with cardiogenic shock or acute respiratory distress syndrome receiving percutaneous ECMO for less than 24h. All consecutive eligible patients will be proposed to participate. They will be randomly allocated in a 1:1 ratio to conventional cannula dressing, or cannula chlorhexidine-impregnated dressing, using an online, central randomisation service, to ensure allocation concealment. Blocked randomization will be performed using random block size. Randomization will be stratified according to center and ECMO type (i.e veno venous or arteriovenous). In both groups, peripheral blood sample will be cultured daily from first day on ECMO to 48h after ECMO removal, death on ECO or ECMO day 30 whichever occurs first. In case of ECMO cannula infection suspicion, deep samples of the cannula will be cultured according to the usual procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients with cardiogenic shock or refractory acute respiratory distress syndrome ECMO VA or VV ECMO for less than 24 hours.
- •ECMO duration > 48 hours
- •Obtained written informed consent from the trusted person or family member/relative. Depending on the emergency consent, randomization may take place and consent of the trusted person/relative/family will be obtained as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when hid/her condition will allow.
- •Affiliation to a social security system (excluding state medical aid)
排除标准
- •Age <18 years
- •Initiation of ECMO for more than 24 hours
- •Surgical (i.e. non percutaneous) cannulation
- •Patient moribund on day of randomization, SAPS II >90
- •Known allergy to chlorhexidine
- •Antibiotic prophylaxis at ECMO cannulation
结局指标
主要结局
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
时间窗: From ECMO initiation date (baseline) and up to day 60
次要结局
- Number of dressing changes for soiling or detachment(From day 1 to 2 days after ECMO weaning date)
- Colonization of ECMO cannulas at Day 7 and weaning from ECMO(Day 7 to 2 days after ECMO weaning date)
- Number of days alive without antibiotics/fungal agents on ECMO(Between day 1 and Day 60)
- Cumulative incidence of ECMO cannula-related bacteremia/fungemia(From ECMO initiation date (baseline) and up to day 60)
- Total duration of ECMO(Between ECMO initiation date (baseline) and ECMO weaning date)
- Cumulative incidence of each cannula infection endpoint in both arms(From ECMO initiation date (baseline) and up to day 60)
- Incidence of contact dermatitis or skin allergy(From ECMO initiation date (baseline) and up to day 60)
- Overall survival(Day7, Day 30, Day 60)
- Number of day in ICU(Between day 1 and Day 60)