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

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.

Conditions

• CLABSI - Central Line Associated Bloodstream Infection

Interventions

DEVICE

Arrow 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

DEVICE

Arrowg+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

Sponsors & Collaborators

• Teleflex

  collaborator INDUSTRY

• University of Malaya

  lead OTHER

Principal Investigators

• Kai Ming Tan · University of Malaya

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-19

Primary Completion

2026-03-03

Completion

2026-03-03

FDA Device

Yes

Countries

• Malaysia

Study Locations