Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Incidence of Nosocomial Infection
研究概览
简要总结
This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).
详细描述
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.
Hypothesis
Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
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
- •Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
- •Anticipated surgical intensive care unit length of stay of 48 hours or more
排除标准
- •Pregnancy
- •Age less than 18 years old
- •Braden score of less than 9 upon admission to the surgical intensive care unit
- •Known allergy to chlorhexidine gluconate
- •Active skin irritation upon admission to the surgical intensive care unit
研究组 & 干预措施
Chlorhexidine gluconate bathing
Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
干预措施: Chlorhexidine gluconate (Drug)
Standard bathing
Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
干预措施: Standard bathing (Other)
结局指标
主要结局
Incidence of Nosocomial Infection
时间窗: Up to 28 days
Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints\* (Composite of new nosocomial infection) * Primary Bloodstream Infection * Catheter Related Urinary Tract Infection * Ventilator-Associated Pneumonia\*\* * Surgical Site Infection (\*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (\*\*)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation.
次要结局
- Number of Patients With In-hospital Mortality(up to 28 days or until first hospital discharge)
- Incidence of Skin Irritation(up to 28 days)
- ICU Length of Stay in Days(up to 28 days)
研究者
Joshua Swan
Sponsor-Investigator/Principal Investigator
The Methodist Hospital Research Institute