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

NCT ID: NCT06804798

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Urosepsis Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The interventional study is between urinary catheter and conventional latex urinary catheter and metal alloy coated urinary catheter
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional latex urinary catheter

Group Type ACTIVE_COMPARATOR

Latex metal alloy coated catheter

Intervention Type DEVICE

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

Latex metal alloy coated catheter

Group Type EXPERIMENTAL

conventional latex urinary catheter

Intervention Type 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.

Interventions

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Latex metal alloy coated catheter

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult more than 18 years old

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Nizam Mokhtar

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FF-2023-056

Identifier Type: -

Identifier Source: org_study_id

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