RecruitingNot ApplicableNCT05959018

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

Efficacy & Health Economics of Antimicrobial-impregnated Central Venous Catheters (CVCs) Compared to Non-impregnated CVCs in Central Line-associated Bloodstream Infection Prevention in a Malaysia University Hospital Adult ICU


Sponsor

University of Malaya

Enrollment

110 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEArrow Three-Lumen Central Venous Catheter

Participants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use

DEVICEArrowg+ard Blue Plus® Three-Lumen Central Venous Catheter

Participants in the Antimicrobial-impregnated CVC arm will receive Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use


Locations(1)

Universiti of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05959018


Related Trials