A clinical study to compare the incidence of Urinary Tract Infection between metal coated urinary catheter and conventional latex urinary catheter in ICU patients

Completed

Conditions: Urinary tract infection, site notspecified,

Registration Number: CTRI/2019/09/021306

Lead Sponsor: Dr BADRI PRASAD DAS

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nosocomial urinary tract infection both bacterial and fungal including frequency of symptomatic catheter associated urinary tract infection and catheter associated asymptomatic bacteriuria	after 3 days of onset of fever or earlier if fever occurs and at every onset of fever

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Sir sunderlal hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Sir sunderlal hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Priya singla
Principal investigator
9999729484
Priyasingla.3192@gmail.com