Vascular Access ComplicationECHO-HDNCT07019610
Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
A study testing ClearGuard HD and B Braun Combi-stopper in people with Vascular Access Complication and Device Related Infection, run by The University of Queensland at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Device Related Infection, Device Related Sepsis
- What is being tested?
- ClearGuard HD and B Braun Combi-stopper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18
- 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.
Who cannot join
- Current CLABSI
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
About this study
Official title: Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Vascular Access Complication, Device Related Infection, Device Related Sepsis, Catheter Infection, Catheter Complications, Catheter-Related Infections
- Being tested
- ClearGuard HD, B Braun Combi-stopper
- Keywords
- Hemodialysis Catheter, Randomised Controlled Trial, Antimicrobial Barrier Caps, Vascular access device, Hemodialysis catheter caps, Chlorhexidine cap, Central Venous Catheter, CVC, CLABSI, Central Line Associated Blood Stream Infection
- Medical subject headings
- Prosthesis-Related Infections, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearGuard HDDevice
Also called Haemodialysis Catheter Luer End Cap
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-stopperDevice
Also called Standard Non-Antimicrobial Hemodialysis Cap
Standard practice caps used within the Metro North Kidney Health Service
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard Non-Antimicrobial Hemodialysis Cap Receives: Device: B Braun Combi-stopper |
| Intervention | Experimental | Antimicrobial Haemodialysis Catheter Luer End Cap Receives: Device: ClearGuard HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility
Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Measured: 12 Months
Recruitment
Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Measured: 12 Months
Fidelity
Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Measured: 12 Months
Missing data
Missing data for primary outcome (<5% of primary outcome data will be unable to be collected).
Measured: 12 Months
Secondary outcomes (5)
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
Measured: 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.
Measured: 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)
Measured: 12 months with 3 month follow up
Antibiotic Use
Antibiotic use (starts due to CLABSI, duration)
Measured: 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
Measured: 12 months with 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-centre, two-arm, parallel group randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Claire Rickard, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019610
- Sponsor's protocol ID
- IVPA_25.01
- Acronym
- ECHO-HD
- Status last verified
- May 2025
- First submitted
- 2 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07019610
- Acronym / sponsor ID
- ECHO-HD / IVPA_25.01
- Conditions
- Vascular Access Complication, Device Related Infection, Device Related Sepsis, Catheter Infection, Catheter Complications, Catheter-Related Infections
- Keywords
- Hemodialysis Catheter, Randomised Controlled Trial, Antimicrobial Barrier Caps, Vascular access device, Hemodialysis catheter caps, Chlorhexidine cap, Central Venous Catheter, CVC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-centre, two-arm, parallel group randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: B Braun Combi-stopperStandard Non-Antimicrobial Hemodialysis Cap |
| Intervention | Experimental | Device: ClearGuard HDAntimicrobial Haemodialysis Catheter Luer End Cap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18
- 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.
Key exclusion criteria (4 listed)
- Current CLABSI
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearGuard HDAlso: Haemodialysis Catheter Luer End CapThe 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. | Device | Intervention |
| B Braun Combi-stopperAlso: Standard Non-Antimicrobial Hemodialysis CapStandard practice caps used within the Metro North Kidney Health Service | Device | Control |
Primary outcome
Eligibility
Time frame: 12 Months
Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Recruitment
Time frame: 12 Months
Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Fidelity
Time frame: 12 Months
Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Missing data
Time frame: 12 Months
Missing data for primary outcome (<5% of primary outcome data will be unable to be collected).
5 secondary outcomes
Central Line Associated Blood Stream Infection (CLABSI) Rates
Time frame: 12 months with 3 month follow up
Catheter Related Infections
Time frame: 12 months with 3 month follow up
Central Venous Catheter (CVC) Failure
Time frame: 12 months with 3 month follow up
Antibiotic Use
Time frame: 12 months with 3 month follow up
Health-related quality of life scores
Time frame: 12 months with 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Rickard principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearGuard HD and B Braun Combi-stopper in people with Vascular Access Complication and Device Related Infection, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jue (Jenny) Wang (+61 450 184 498, jue.wang@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.