A Phase 4 interventional study of Latex metal alloy coated catheter and conventional latex urinary catheter in Sepsis, Urosepsis and Intensive Care Unit, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by National University of Malaysia · Phase 4, Interventional, and Treatment
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's enrollment of 76 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
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Inclusion criteria
Device: Latex metal alloy coated catheter
Device: conventional latex urinary catheter
Metal alloy works as an antiseptic whereby preventing the attachment of biofilm to the catheter lining.
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.
To Compare
To compare catheter associated urinary tract infections rate between conventional latex urinary catheter and latex metal alloy
Time frame: 2 years
To compare
To compare the rate of bacteremia from catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Time frame: 2 years
To compare
To compare the common types of microorganisms associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Time frame: 2 years
To compare
To compare risk factor that is associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Time frame: 2 years
To compare
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
Time frame: 2 years
Length of stay
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
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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National University of Malaysia