Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
NCT ID: NCT07019610
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-31
2028-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Standard Non-Antimicrobial Hemodialysis Cap
B Braun Combi-stopper
Standard practice caps used within the Metro North Kidney Health Service
Intervention
Antimicrobial Haemodialysis Catheter Luer End Cap
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.
Interventions
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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.
B Braun Combi-stopper
Standard practice caps used within the Metro North Kidney Health Service
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)
* 21 days BSI free
* No known allergy to chlorhexidine and/or nylon and/or polypropylene.
Exclusion Criteria
* Known allergic to chlorhexidine and/or nylon and/or polypropylene.
* Patients on an end-of-life pathway
* People with a cognitive impairment and/or intellectual disability
18 Years
ALL
No
Sponsors
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Royal Brisbane and Women's Hospital
OTHER_GOV
The University of Queensland
OTHER
Responsible Party
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Principal Investigators
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Claire Rickard
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Locations
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Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Countries
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Central Contacts
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Other Identifiers
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IVPA_25.01
Identifier Type: -
Identifier Source: org_study_id
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