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Evaluation of Catheter Associated Urinary Tract Infection Between Metal Alloy Coated Catheter and Conventional Latex Catheter in Critically Ill Patients

NCT06804798 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Urosepsis
  • Intensive Care Unit

Interventions

DEVICE

Latex metal alloy coated catheter

Metal alloy works as an antiseptic whereby preventing the attachment of biofilm to the catheter lining.

DEVICE

conventional latex urinary catheter

Latex catheters prove to be soft, flexible, inexpensive and thermo-sensitive towards body temperature. However, there is a risk of developing CAUTI as bacteria are more susceptible to adhere to latex.

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-07-01
Completion
2024-11-01

Countries

  • Malaysia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06804798 on ClinicalTrials.gov