The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service. The main questions to answer are: * Study Feasibility * Occurrence of infectious complications related to renal central venous catheters Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub: * The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or * The intervention hemodialysis cap containing chlorhexidine inside it Researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.
This study is a single-centre, two-arm, parallel group Randomized Controlled Trial (RCT) to test the effectiveness, safety, impact of device application on health-related quality of life measures, and cost-effectiveness of ClearGuard™ HD antimicrobial barrier caps in patients receiving hemodialysis. Setting and Sample: The ECHO-HD will be undertaken at the Metro North Kidney Health Service (MNKHS), Royal Brisbane and Women's Hospital in Queensland, Australia. Sample Size: The investigators will recruit 60 patients with 30 patients per arm. The purpose of the pilot study is to assess research project feasibility and inform the design of a large scale powered RCT. Viechtbauer et al. (2015) determined that a sample size of 59 participants is sufficient to detect a problem with a 5% probability of occurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The ClearGuard HD end cap is a male luer lock end cap that incorporates an antimicrobial treatment (Chlorhexidine) on its surface designed to reduce microbial colonisation within a haemodialysis catheter hub.
Standard practice caps used within the Metro North Kidney Health Service
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Eligibility
Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Time frame: 12 Months
Recruitment
Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Time frame: 12 Months
Fidelity
Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Time frame: 12 Months
Missing data
Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected).
Time frame: 12 Months
Central Line Associated Blood Stream Infection (CLABSI) Rates
CLABSIs incidence rates (reported as the CLABSI rate per 1000 central line days, which is calculated by dividing the number of CLABSIs by the number of central line days and multiplying the result by 1000 (CDC, 2024) Hospitalisation days for CLABSI
Time frame: 12 months with 3 month follow up
Catheter Related Infections
Central line related infections, defined as infections other than bloodstream infections caused by a central line insertion/insitu such as local skin infections etc.
Time frame: 12 months with 3 month follow up
Central Venous Catheter (CVC) Failure
Central Venous Catheter (CVC) failure/complications (catheter removal due to infection, occlusion and other complications)
Time frame: 12 months with 3 month follow up
Antibiotic Use
Antibiotic use (starts due to CLABSI, duration)
Time frame: 12 months with 3 month follow up
Health-related quality of life scores
Health-related quality of life scores using EuroQual 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire (see attached User Agreement and EQ-5D-5L Questionnaire
Time frame: 12 months with 3 month follow up
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