An interventional study of ClearGuard HD and B Braun Combi-stopper in Vascular Access Complication, Device Related Infection and Device Related Sepsis, sponsored by The University of Queensland. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by The University of Queensland · Not applicable, Interventional, and Prevention
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:
Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub:
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.
39 studies on the registry are indexed under Prosthesis-Related Infections; 10 are open to participants now.
This study's planned enrollment of 60 is below the median of 193 across 22 interventional studies indexed under Prosthesis-Related Infections.
Browse Prosthesis-Related Infections studies →The University of Queensland is the lead sponsor of 89 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard Non-Antimicrobial Hemodialysis Cap
Device: B Braun Combi-stopper
Antimicrobial Haemodialysis Catheter Luer End Cap
Device: ClearGuard HD
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.
Also known as: Haemodialysis Catheter Luer End Cap
Standard practice caps used within the Metro North Kidney Health Service
Also known as: Standard Non-Antimicrobial Hemodialysis Cap
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Prosthesis-Related Infections→
The University of Queensland