Incidence of bacterial and fungal Urinary Tract Infection with metal alloy impregnated urinary catheter (BIP foley catheter) in comparison to conventional latex foley catheter in ICU- a prospective interventional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Incidence of nosocomial urinary tract infection both bacterial and fungal including frequency of symptomatic catheter associated urinary tract infection and catheter associated asymptomatic bacteriuria
Study Overview
Brief Summary
All the adult patients between age group 18-60 years who were fulfilling the inclusion criteria were included in our study. Total patients recruited were 200 and these were randomised into group A(conventional foley catheter) and group B( BIP foley catheter) but due to covid pandemic we could not recruit the patients as targeted so total 153 patients were analysed. The primary end point,CAUTI was significantly less in group with metal alloy impregnated foley catheter(BIP foley catheter) as compared to conventional foley catheter(3.7 per 1000 catheter days vs 13.7 per 1000 catheter days with p value 0.006). As stated by secondary end point, less mortality was observed in griup with BIP foley catheter as compared to conventional foley catheter(25% vs 31.3%). This was clinically significant but not stastically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients(>18 years and <60 years) Admitted with any critical illness No UTI Requiring a urinary catheter for atleast 3 days Using a closed drainage system Will be included in the study.
Exclusion Criteria
- •Children Patients with UTI Known case if BPH Patients using open drainage system Any congenital urinary tract abnormalities or obstetrics/gyanaecological abnormalities Patients with duration of catheter< 3 days Diabetic patients Will be excluded from the study.
Outcomes
Primary Outcomes
Incidence of nosocomial urinary tract infection both bacterial and fungal including frequency of symptomatic catheter associated urinary tract infection and catheter associated asymptomatic bacteriuria
Time Frame: after 3 days of onset of fever or earlier if fever occurs and at every onset of fever
Secondary Outcomes
- To assess safety and cost effectiveness clinical outcome in form of 30 days mortality(Till 30 days or earlier when it needs to be removed due to blockage or patient dies or patient is shifted to ward)