CompletedNot Applicable

Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU

Malaysia110 participantsStarted 2024-01-19

Plain-language summary

Central venous catheters (CVCs) are indispensable in modern critical care. However, CVC usage is associated with complications, including central line-associated bloodstream infections (CLABSIs), which in turn, is translated to higher healthcare costs and mortality. The use of antimicrobial-impregnated CVCs is one of the strategies to reduce CLABSI. Nevertheless, its' efficacy and beneficial effects, particularly in terms of patients' outcome had not been homogeneously demonstrated across literature. Moreover, antimicrobial-impregnated CVCs are more expensive compared to conventional non-impregnated ones, and hence its cost-effectiveness remains doubtful. To date, no local studies have been conducted to evaluate the efficacy and economic impact of antimicrobial-impregnated CVCs and on patients' outcome. The goal of this clinical trial is to determine the efficacy and cost-effectiveness of antimicrobial-impregnated CVCs in preventing (CLABSI) among critically ill patients in a Malaysia University Hospital Adult Intensive Care Unit. The main questions it aims to answer are: 1. Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU? 2. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in Malaysia adult ICU affect patient length of stay when compared to non- impregnated CVCs? 3. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs? 4. How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs? Patients who require a CVC for critical care in ICU will be recruited and randomly assigned to one of the two different groups to receive either a conventional non-impregnated CVC or an antimicrobial-impregnated CVC, which will be inserted and handled by medical practitioners. Participants will then be monitored for symptoms and signs of CLABSI, alongside length of ICU stay \& healthcare costs. Researchers will compare CLABSI rates and other relevant parameters among the 2 groups to see if antimicrobial-impregnated CVCs are useful and cost-effective in CLABSI prevention.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period * Patients who require a CVC during ICU stay Exclusion Criteria: * Patients who refuse to participate in the study * Patients with known hypersensitivity reaction to CVC materials * Patients with pre-existing diagnosis of CLABSI upon admission to the ICU * Patients with pre-existing bloodstream infection upon admission to the ICU * Patients with a pre-existing CVC, where sterility during placement may be compromised (e.g. in an emergency situation) * Patients with indwelling CVC less than 48 hours * Patients who had poor compliance to catheter bundle care during CVC handling throughout the indwelling catheter period * Patients who require \> 1 CVC or other central venous access

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Central line-associated bloodstream infection (CLABSI) rate

Timeframe: Through study completion, tentatively up to 1 year

Trial details

NCT IDNCT05959018

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-03

View on ClinicalTrials.gov More CLABSI - Central Line Associated Bloodstream Infection trials