Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia
NCT Number: NCT06804798
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 2 years
To compare catheter associated urinary tract infections rate between conventional latex urinary catheter and latex metal alloy
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
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
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
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
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
National University of Malaysia
Other
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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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