A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,994
- 试验地点
- 2
- 主要终点
- Incidence of catheter-related urinary tract infection
研究概览
简要总结
The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:
- Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.
- CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
- CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.
详细描述
This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):
Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.
Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.
Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of catheter-related urinary tract infection
时间窗: During the entire observation period (12 months)
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)
次要结局
- Incidence of catheter-related urinary tract infection (including candiduria)(During the entire observation period (12 months))
- Incidence of catheter-related urinary tract infection, by different clinical relevant isolates(During the entire observation period (12 months))