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NCT Number: NCT07019610

Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled 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:

* 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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Key information

Conditions

Vascular Access Complication Catheter Complications Catheter Infection Catheter Related Complications Catheter-Related Infections Device Related Infection Device Related Sepsis Hemodialysis Catheter Infection Hemodialysis Catheter-associated Infection Hemodialysis Complication Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis-Related Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

ClearGuard HD

Device

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.

Other names: Haemodialysis Catheter Luer End Cap

B Braun Combi-stopper

Device

Standard practice caps used within the Metro North Kidney Health Service

Other names: Standard Non-Antimicrobial Hemodialysis Cap

Primary outcomes

  1. Eligibility

    Time frame: 12 Months

    Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)

  2. Recruitment

    Time frame: 12 Months

    Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)

  3. Fidelity

    Time frame: 12 Months

    Protocol fidelity of study participants (≥80% will receive the allocated intervention)

  4. Missing data

    Time frame: 12 Months

    Missing data for primary outcome (<5% of primary outcome data will be unable to be collected).

Secondary outcomes

  1. Central Line Associated Blood Stream Infection (CLABSI) Rates

    Time frame: 12 months with 3 month follow up

    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

  2. Catheter Related Infections

    Time frame: 12 months with 3 month follow up

    Central line related infections, defined as infections other than bloodstream infections caused by a central line insertion/insitu such as local skin infections etc.

  3. Central Venous Catheter (CVC) Failure

    Time frame: 12 months with 3 month follow up

    Central Venous Catheter (CVC) failure/complications (catheter removal due to infection, occlusion and other complications)

  4. Antibiotic Use

    Time frame: 12 months with 3 month follow up

    Antibiotic use (starts due to CLABSI, duration)

  5. Health-related quality of life scores

    Time frame: 12 months with 3 month follow up

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jue (Jenny) Wang

CONTACT

[email protected]

+61 450 184 498

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • Royal Brisbane and Women's Hospital

Registry information

Official study title

Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial

Acronym: ECHO-HD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 13, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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