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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Central line-associated bloodstream infection (CLABSI) rate
研究概览
简要总结
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:
- Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
- 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?
- Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
- 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.
详细描述
Central venous catheters (CVCs) are indispensable in modern critical care. The average central line utilisation ratios in the ICUs across 45 countries were reported at 0.525.
However, CVC usage is associated with complications, including central line-associated bloodstream infections (CLABSIs). The rate of CLABSI is reported at 4.45 per 1000 central line days in ICUs across 45 countries from 2013 - 2018. This in turn, is translated to higher healthcare costs and mortality.
Antimicrobial-impregnated CVCs are proposed to be able to reduce the incidence of CLABSI by inhibiting microorganism colonisation on CVCs. A meta-analysis published in 2018 concluded that antimicrobial-impregnated CVCs were significantly effective in reducing CLABSIs and catheter colonisations.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter
Control group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter
干预措施: Arrow Three-Lumen Central Venous Catheter (Device)
Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter
Group who receives antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter
干预措施: Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter (Device)
结局指标
主要结局
Central line-associated bloodstream infection (CLABSI) rate
时间窗: Through study completion, tentatively up to 1 year
CLABSI cases per 1000 catheter days
次要结局
- ICU Length of stay of patients diagnosed with CLABSI(Through study completion, tentatively up to 1 year)
- Healthcare costs of patients diagnosed with CLABSI(Through study completion, tentatively up to 1 year)
- Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI(Through study completion, tentatively up to 1 year)
- Percentages of specific bacterial species isolated from patients diagnosed with CLABSI(Through study completion, tentatively up to 1 year)
研究者
Tan Kai Ming
Principal Investigator/ Postgraduate Student
University of Malaya