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Completed

NCT Number: NCT06804798

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult more than 18 years old
  • Indwelling urinary catheter more than 48 hours Exclusion Criteria
  • 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

Treatment and study plan

Latex metal alloy coated catheter

Device

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

conventional latex urinary catheter

Device

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.

Primary outcomes

  1. To Compare

    Time frame: 2 years

    To compare catheter associated urinary tract infections rate between conventional latex urinary catheter and latex metal alloy

Secondary outcomes

  1. To compare

    Time frame: 2 years

    To compare the rate of bacteremia from catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter

  2. To compare

    Time frame: 2 years

    To compare the common types of microorganisms associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter

  3. To compare

    Time frame: 2 years

    To compare risk factor that is associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter

  4. To compare

    Time frame: 2 years

    To compare the incidence of acute kidney injury (AKI) in catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter

  5. Length of stay

    Time frame: 2 years

    To determine length of stay in ICU and ICU mortality in catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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