Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12,000
- 试验地点
- 2
- 主要终点
- A composite of healthcare-associated infections
研究概览
简要总结
Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.
Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).
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 (Investigator)
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 admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center
排除标准
- •Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
- •Patients with known allergy to chlorhexidine gluconate
- •Age < 18 years old
- •Patients where daily bathing would not be safe
结局指标
主要结局
A composite of healthcare-associated infections
时间窗: Daily
A composite of the following healthcare-associated infections: 1. Central line-associated blood stream infections (CLABSI) 2. Possible or probable ventilator associated pneumonia (VAP) 3. Catheter-associated urinary tract infection (CAUTI) 4. C. difficile-associated diarrhea
次要结局
- Rates of each individual site infection included in the composite calculation above(Daily)
- Skin reactions(As needed)
- Hospital mortality(One year)
- Hospital length of stay(One year)
- ICU length of stay(One year)
- Rate of cultures positive for multi-drug resistant organisms(Daily)
- Rates of blood culture contamination(Daily)
- Rates of healthcare-acquired bloodstream infections(Daily)
研究者
Michael Noto
Clinical Fellow, Division of Allergy, Pulmonary, and Critical Care Medicine
Vanderbilt University