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

NCT06804798 | Completed Phase 4

• 1 other identifier: FF-2023-056
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Urosepsis; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• To Compare

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

  2 years

Secondary Outcomes (5)

• To compare

  2 years

• To compare

  2 years

• To compare

  2 years

• To compare

  2 years

• Length of stay

  2 years

Study Arms (2)

Conventional latex urinary catheter

ACTIVE COMPARATOR

Device: Latex metal alloy coated catheter

Latex metal alloy coated catheter

EXPERIMENTAL

Device: conventional latex urinary catheter

Interventions

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

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.

Latex metal alloy coated catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult more than 18 years old

You may not qualify if:

• \. 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: The interventional study is between urinary catheter and conventional latex urinary catheter and metal alloy coated urinary catheter

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

MY (1)