Clinical trial NCT06804798: Evaluation of Catheter Associated Urinary Tract Infection Between Metal Alloy Coated Catheter and Conventional Latex Catheter in Critically Ill Patients
Official title: Evaluation of Catheter Associated Urinary Tract Infection Between Metal Alloy Coated Catheter and Conventional Latex Catheter in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Urosepsis
Intensive Care Unit
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study is between urinary catheter and conventional latex urinary catheter and metal alloy coated urinary catheter
Primary purpose: TREATMENT

Brief summary: This is a prospective single blinded randomized trial to evaluate the incidence of catheter associated urinary tract infection (CAUTI) between latex catheter and metal alloy coated catheter among Intensive Care Unit (ICU) patients. CAUTI has a few definitions, in this study, we will follow the latest Central of Disease Control (CDC) guideline definition of CAUTI in January 2022.

This study involves 100 patients who meet the inclusion and exclusion criteria that have been set. The patients will be divided into group A and group B and two types of catheters will be given out to the healthcare workers according to the randomization. Data collection involves demographic, medical and laboratory data and will be documented in the tables provided. All data will be collected from day of urinary catheterization in ICU until patients discharge or die or maximum of 14 days in ICU or develop CAUTI or ABUTI or whichever that occurred earlier. Patients who died within 48 hours of catheter insertion, will be considered as drop-out.

Data that has been extrapolated from this study will then give us an insight regarding the best type of catheter to avoid CAUTI, risk factors associated with CAUTI and to determine length of ICU stay and ICU morbidity with patients who have CAUTI. This study proves to be important in reducing the overall healthcare associated infection in the ICU setting.


Eligibility criteria: Inclusion criteria

1. Adult more than 18 years old
2. Indwelling urinary catheter more than 48 hours Exclusion Criteria

1. Community urosepsis 2. Chronic kidney disease and end stage renal failure 3. Suprapubic catheter 4. Patient with dependent urinary catheter 5. Pregnant ladies 6. Congenital urinary tract abnormality 7. Surgical procedure involving urinary tract 8. Moribound patient or expected to die within 24 hours 9. Discharged to ward within 48 hours 10. Latex allergy

Primary outcomes:
measure: To Compare
timeFrame: 2 years
Secondary outcomes:
measure: To compare
timeFrame: 2 years
measure: To compare
timeFrame: 2 years
measure: To compare
timeFrame: 2 years
measure: To compare
timeFrame: 2 years
measure: Length of stay
timeFrame: 2 years
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
References: