Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,730
- 试验地点
- 16
- 主要终点
- Composite of healthcare-associated infections (HAI)
研究概览
简要总结
Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.
详细描述
Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •All patients ≥ 18 years/old admitted to the participants's ICUs
排除标准
- •History of chlorhexidine allergy
研究组 & 干预措施
Chlorhexidine baths
All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
干预措施: 2% chlorhexidine digluconate solution with surface-active agents (Other)
Usual baths
All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
干预措施: Usual Baths (Other)
结局指标
主要结局
Composite of healthcare-associated infections (HAI)
时间窗: Within each cluster duration (90 days)
Composite outcome of the following HAI: Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)
次要结局
- Rates of multi-drug-resistant pathogens(Within each cluster duration (90 days))
- Antibiotic use(Within each cluster duration (90 days))
- Intensive Care Unit length of stay(Until Intensive Care Unit discharge, maximum 90 days)
- Ventilator associated pneumonia (VAP)(Within each cluster duration (90 days))
- Central line-associated blood stream infections (CLABSI)(Within each cluster duration (90 days))
- Catheter-associated urinary tract infection (CAUTI)(Within each cluster duration (90 days))
- Hospital length of stay(Until hospital discharge, maximum 90 days)
- In hospital mortality(Maximum 90 days after randomization)
- Intensive Care Unit mortality(Maximum 90 days after randomization)