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

NCT07019610 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IVPA_25.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Device Related Sepsis; Catheter Infection; Catheter Complications; Hemodialysis Complication; Device Related Infection; Catheter-Related Infections; Catheter Related Complications; Hemodialysis Catheter Infection; Hemodialysis Catheter-associated Infection; Vascular Access Complication

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

Outcome Measures

Primary Outcomes (4)

• Eligibility

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

  12 Months

• Recruitment

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

  12 Months

• Fidelity

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

  12 Months

• Missing data

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

  12 Months

Secondary Outcomes (5)

• Central Line Associated Blood Stream Infection (CLABSI) Rates

  12 months with 3 month follow up

• Catheter Related Infections

  12 months with 3 month follow up

• Central Venous Catheter (CVC) Failure

  12 months with 3 month follow up

• Antibiotic Use

  12 months with 3 month follow up

• Health-related quality of life scores

  12 months with 3 month follow up

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard Non-Antimicrobial Hemodialysis Cap

Device: B Braun Combi-stopper

Intervention

EXPERIMENTAL

Antimicrobial Haemodialysis Catheter Luer End Cap

Device: ClearGuard HD

Interventions

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.

Also known as: Haemodialysis Catheter Luer End Cap

Intervention

B Braun Combi-stopper DEVICE

Standard practice caps used within the Metro North Kidney Health Service

Also known as: Standard Non-Antimicrobial Hemodialysis Cap

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18
• Able to provide informed consent
• Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)
• days BSI free
• No known allergy to chlorhexidine and/or nylon and/or polypropylene.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead
• Royal Brisbane and Women's Hospital: collaborator

Study Sites (1)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

MeSH Terms

Conditions

Prosthesis-Related Infections; Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire Rickard

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jue (Jenny) Wang

CONTACT

+61 450 184 498; jue.wang@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-centre, two-arm, parallel group randomised controlled trial.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 13, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)