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

NCT07019610 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-29

No results posted yet for this study

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

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

Interventions

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.

DEVICE

B Braun Combi-stopper

Standard practice caps used within the Metro North Kidney Health Service

Sponsors & Collaborators

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Claire Rickard · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2028-02-29
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019610 on ClinicalTrials.gov