Efficacy of the catheter associated urinary tract infections (CAUTI) prevention device - UTINIL in patients with indwelling urinary catheter: A randomized controlled double blind study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Urinary bacterial colony count during catheter indwelling period between two groups
研究概览
简要总结
Catheter Associated Urinary Tract Infections [CAUTI] is one of the most common hospital acquired infections. Each day the indwelling catheter remains, risk of acquiring CAUTI increases by 3-7% as per CDC Reference of January 2024. The consequences of untreated CAUTI associated with excess morbidity, mortality, antimicrobial agent use and health care costs. This new device used in our study is a novel add-on device which focuses on both extraluminal and intraluminal routes of infections. It might be effective in prevent both endogenous and exogenous bacteria ascending to the urinary bladder. The device irradiates UV light which might be effective in disinfecting the bacteria and also releases low-frequency vibration/ surface acoustic waves (SAW) which may have potential to prevent biofilm formation and bacterial colonization on the catheter surface. It will not increase the antimicrobial resistance burden. There is currently no evidence available which shows that combining UV light to surface acoustic wave via a single device can confer better prevention from UTI than standard catheter care. This study aims to find the combined effect of these two modalities in prevention of CAUTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients of more than 18 years age being admitted to ICU requiring Foleys catheterization.
排除标准
- •Active UTI or history of UTI or Culture proven UTI within past 14 days
- •History of urological surgery or trauma
- •History of renal pathology
- •Expected discharge or survival in ICU less than 48 hours.
结局指标
主要结局
Urinary bacterial colony count during catheter indwelling period between two groups
时间窗: At Day 10 of catheterisation
次要结局
- Incidence of UTI (cases /1000 catheter days) in catheterized ICU patients with and without the device(Within 10 days of catheterisation)
- Incidence of asymptomatic bacteriuria and candiduria(Within 10 days of catheterisation)
- Incidence of catheter blockage(Within 10 days of catheterisation)
研究者
Premangshu Ghoshal
All India Institute Of Medical Sciences, New Delhi
