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
Phase: NA
Conditions: CLABSI - Central Line Associated Bloodstream Infection
Sponsor: University of Malaya

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RESEARCH PROTOCOL 
 
 
PARTICULARS OF RESEARCHER 
 
Full Name: Ina Ismiarti binti Shariffuddin 
Title: Professor Dr 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Office Contact Number: 03-7949 2052 
Mobile Number: 012-2353134 
Email: ismiarti@ummc.edu.my 
Research Expertise: Anaesthesiology, Intensive Care 
 
 
LIST OF CO-RESEARCHERS 
 
 
Prof Dr Rafidah binti Atan 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Email: rafidah.atan@ummc.edu.my 
 
Associate Prof Dr Chaw Sook Hui 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Email: sook_hui@ummc.edu.my 
 
Dr Mayura Hanis binti Ahmad Damanhuri 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Email: mayura@ummc.edu.my 
 
Dr Ngoi Soo Tein 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Email: ngoisootein@um.edu.my 
 
Dr Tan Kai Ming 
Department: Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya 
Email: tankaiming@ummc.edu.my 

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RESEARCH PROPOSAL 
 
RESEARCH TITLE 
Efficacy and Health Economics of Antimicrobial-impregnated Central Venous Catheters 
(CVCs) compared to Non-impregnated CVCs in Central Line-associated Bloodstream 
Infection (CLABSI) Prevention in a Malaysia University Hospital Adult Intensive Care Unit 
(ICU) 
 
Keywords: Antimicrobial-impregnated Central Venous Catheters (CVCs), Central Line- 
associated Bloodstream Infection (CLABSI), Intensive Care Unit (ICU) 
 
1.  INTRODUCTION 
 
Central venous catheters (CVCs) are indispensable in modern critical care as they are highly 
reliable as intravenous access for administration of vasopressors, inotropes, irritant solutions, 
total parenteral nutrition and for haemodynamic monitoring. The average central line 
utilisation ratios in the ICUs across 45 countries were reported at 0.525 (Rosenthal et al., 
2021). 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 (Rosenthal et al., 2021). This in turn, is translated to increased healthcare 
costs and mortality. One of the strategies to reduce the incidence of CLABSI is the use of 
antimicrobial-impregnated CVCs. These antimicrobial-impregnated CVCs, which can be 
coated with either antibiotics (e.g. rifampin, minocycline, etc.) or antiseptics (e.g. 
chlorohexidine, silver sulphadiazine, benzalkonium chloride, etc.) or both, 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 (Wang et al., 
2018). Nevertheless, its efficacy and beneficial effects, particularly in terms of patients’ 
outcome had not been homogenously demonstrated across literature. Moreover, 
antimicrobial-impregnated CVCs are more expensive compared to non-impregnated ones, 
and hence its cost-effectiveness remains doubtful. 
 
To date, in our local setting, no study evaluates the efficacy and economic impact of 
antimicrobial-impregnated CVCs and on patients’ outcome. Cost-effectiveness evaluation is 
important to provide value-based care in clinical practice. This study aims to evaluate the 
clinical and economic treatment of antimicrobial-impregnated CVCs vs Non-impregnated 
CVCs in prevention of CLABSI. 
 
1.1 Research Questions 
1.  Is there any difference in central line-associated bloodstream infection (CLABSI) 
rates between patients using antimicrobial-impregnated central venous catheters 
(CVCs) and non-impregnated CVCs in Malaysia adult Intensive Care Unit (ICU)? 

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2. Does the use of antimicrobial-impregnated central venous catheters (CVCs) in 
central line-associated bloodstream infection (CLABSI) prevention in Malaysia adult 
Intensive Care Unit (ICU) affect patient length of stay when compared to non- 
impregnated CVCs? 
3. Does the use of antimicrobial-impregnated central venous catheters (CVCs) in 
central line-associated bloodstream infection (CLABSI) prevention in the adult 
Intensive Care Unit (ICU) setting affect healthcare costs when compared to non- 
impregnated CVCs? 
4. How antimicrobial resistance features of the bacteria causing central line-associated 
bloodstream infection (CLABSI) may differ in patients using antimicrobial- 
impregnated central venous catheters (CVCs) compared to non-impregnated CVCs? 
2.  OBJECTIVES 
 
Primary objective: 
● To compare the incidence of central line-associated bloodstream infection (CLABSI) 
rate in patients using antimicrobial-impregnated central venous catheter (CVCs) and 
non-impregnated CVCs in Malaysia adult Intensive Care Unit (ICU) 
 
Secondary objectives: 
● To determine the length of stay of patients using antimicrobial-impregnated central 
venous catheter (CVCs) vs non-impregnated CVCs in Malaysia adult Intensive Care 
Unit (ICU) 
● To undertake a cost-effectiveness analysis in prevention of central line-associated 
bloodstream infection (CLABSI) between patients using antimicrobial-impregnated 
central venous catheters (CVCs) and non-impregnated CVCs in Malaysia adult 
Intensive Care Unit (ICU) 
● To compare the antimicrobial resistance features of the bacterial species that caused 
central line-associated bloodstream infection (CLABSI) between patients using 
antimicrobial-impregnated central venous catheter (CVCs) and that of non- 
impregnated CVCs in Malaysia adult Intensive Care Unit (ICU) 
3.  METHODOLOGY 
 
3.1 Study Location 
The study will be conducted in the adult Intensive Care Unit (ICU) of Universiti Malaya 
Medical Centre (UMMC), which is a mixed medical/surgical ICU. 
 
3.2 Study Period 
The study will be conducted over a period of one year. 
 
3.3 Study Design 
The study will be conducted as a randomised-controlled trial. 

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3.4 Study Population 
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 central line-associated bloodstream infection 
(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 
 
3.5 Sampling Method 
All adult patients who require a CVC insertion as part of their standard routine treatment in 
ICU will be recruited. After the recruitment, the patients will be randomly assigned to one 
of the two different groups using a computer: control group who receives non-impregnated 
CVC and investigational group who receives antimicrobial-impregnated CVC. 
 
3.6 Sample Size 
Our local data at ICU, UMMC reported the incidence of CLABSI per 1000 catheter days in 
the first 6 months of 2022, to be 12.18. Using SAS® for sample size calculation, in order to 
detect a clinically significant reduction of CLABSI by 30%, and assuming a two-sided type 
I error protection of 0.05 and a power of 0.80, we calculated a sample size of 50 patients is 
required. To incorporate a 10% drop out rate, we therefore aim to recruit 55 patients in each 
arm (antimicrobial-impregnated CVCs, n=55; non-impregnated CVCs, n=55). This will 
make up to a total sample size of 110. 
 
3.7 Variables/ Parameters 
3.7.1 Dependent Variables 
3.7.1.1 Primary Outcome 
The primary outcome investigated is the central line-associated bloodstream infection 
(CLABSI) rate, expressed in cases per 1000 catheter days. The diagnosis of CLABSI will be 
based on the CDC-NHSN definition. 

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3.7.1.2 Secondary Outcomes 
The secondary outcomes investigated included: 
i. 
ICU Length of stay of patients diagnosed with CLABSI 
ii. 
Healthcare costs of patients diagnosed with CLABSI 
iii. 
Antimicrobial resistance profiles of the bacterial species isolated from patients 
diagnosed with CLABSI 
 
3.7.2 Other Parameters 
Baseline patient data will be included as concomitant study parameters. Relevant patient and 
clinical data including basic demographic information (age, gender, and ethnicity), known 
underlying diseases, previous antibiotic exposure within 90 days, and admission date will be 
extracted from the clinical database for correlation and risk factor analyses. 
 
For patients diagnosed with CLABSI, information including the number of days a patient 
spent in the hospital prior to strain isolation, number of days and type(s) of antibiotics used 
in said patient, hospital-generated antibiograms for each strain, patient risk factors for 
nosocomial infection associated with an isolate, previous surgeries or hospitalizations of the 
patient prior to isolation, location of a patient within the hospital prior to strain isolation and 
ICU admission, and any other information pertinent to a specific strain that will not identify 
a patient will be collected. 
 
3.8 Data Collection 
3.8.1 Clinical and patient data collection 
A form comprising all study parameters will be prepared for data recording and collection. 
The data will be collected and handled confidentially by the investigators. 
 
3.8.2 Bacterial strains collection and molecular assays 
For patients who develop CLABSI during their ICU stay, routine blood culture will be 
obtained and processed at the Medical Microbiology Diagnostic Laboratory, UMMC to 
identify the bacterial species. Bacterial species identification and antimicrobial susceptibility 
testing will be conducted using an automated VITEK 2 system (bioMerieux, Marcy-l’Etoile, 
France), according to standardized protocols. All bacterial strains will be transported to the 
bacteriology research laboratory at the Department of Medical Microbiology, Faculty of 
Medicine, UM for further molecular analyses. Polymerase chain reaction (PCR) assays will 
be conducted to further confirm the identity and genotypes of the bacterial isolates and to 
determine the antimicrobial resistance-conferring genes that corresponded to the 
antimicrobial resistance phenotypes of the isolates. Established primer sequences from 
previous studies will be adapted and PCR assays will be performed using optimized 
laboratory protocols (Ngoi et al., 2021; Muhamad et al., unpublished data). No additional 
biological samples will be taken in addition to routine practice and no additional invasive 
procedures will be performed on the study participants. Hence, there will be no added 
potential harm to the study participants. The costs for further molecular analyses will be 
covered by the grant and will not be borne by the patients. 

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3.9 Data Analysis 
The data will be analysed using the SPSS Software. Descriptive statistics will be expressed 
as percentages unless otherwise stated. Categorical variables will be expressed as 
percentages and compared using the Chi-square or Fisher’s exact test, whichever is 
appropriate. Variables with a univariate test value of less than 0.05 (p-value) will be included 
in a multivariate analysis using a logistic regression model. Odds ratios (OR) and 95% 
confidence intervals (CI) will be calculated to identify the risk factors associated with the 
development of CLABSI in patients. In all instances, a p-value of less than or equal to 0.05 
will be considered significant. 
FUNDING 
 
This study will be funded by Teleflex Research Grant (RM50000). 
RESEARCH DATA MANAGEMENT 
 
All data collected will be handled confidentially according to the Good Clinical Practice 
Guidelines. The paper case report forms will be stored within a locked cabinet at the 
Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya. The electronic 
case report forms will be kept in a password-protected laptop. Only the study investigators 
will have access to the research data. The data will be kept for seven years upon completion 
of study. The results of the study will be reported in a thesis. The results will also be 
presented in conferences and published in scientific journals. 
POTENTIAL RESEARCH IMPACT 
 
The usage of antimicrobial-impregnated central venous catheters (CVCs) among adult 
critically ill patient in the Intensive Care Unit (ICU) can reduce central line-associated 
bloodstream infections (CLABSIs) and this will translate to reduced patients’ length of stay 
and healthcare costs. 

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GANTT CHART 
 
 
2023 
2024 
Research Activities 
3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12
Ethics submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Completion and submission 
of manuscript 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication and scientific 
presentations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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