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

ConditionsVascular Access ComplicationDevice Related InfectionDevice Related SepsisCatheter InfectionCatheter ComplicationsCatheter-Related InfectionsCatheter Related ComplicationsHemodialysis Catheter InfectionHemodialysis Catheter-associated InfectionHemodialysis Complication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Queensland

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18

Able to provide informed consent

Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)

21 days BSI free

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • B Braun Combi-stopper

    Device

    Standard practice caps used within the Metro North Kidney Health Service

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility

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

Time frame
12 Months
2

Recruitment

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

Time frame
12 Months
3

Fidelity

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

Time frame
12 Months
4

Missing data

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

Time frame
12 Months

Secondary outcomes

1

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

Time frame
12 months with 3 month follow up
2

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.

Time frame
12 months with 3 month follow up
3

Central Venous Catheter (CVC) Failure

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

Time frame
12 months with 3 month follow up
4

Antibiotic Use

Antibiotic use (starts due to CLABSI, duration)

Time frame
12 months with 3 month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Royal Brisbane and Women's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: