跳至主要内容
临床试验/CTRI/2025/08/093136
CTRI/2025/08/093136招募中3 期

Efficacy of the catheter associated urinary tract infections (CAUTI) prevention device - UTINIL in patients with indwelling urinary catheter: A randomized controlled double blind study

Dr Premangshu Ghoshal1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月1日最近更新:

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

发起方
Dr Premangshu Ghoshal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Premangshu Ghoshal

All India Institute Of Medical Sciences, New Delhi

研究点 (1)

Loading locations...

相似试验