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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07019610
• Lead Sponsor: The University of Queensland

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.

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-08
• Primary Completion: 2027-12
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eligibility	12 Months	Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Recruitment	12 Months	Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Fidelity	12 Months	Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Missing data	12 Months	Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected).

Secondary Outcome Measures

Name	Time	Method
Central Line Associated Blood Stream Infection (CLABSI) Rates	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
Catheter Related Infections	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.
Central Venous Catheter (CVC) Failure	12 months with 3 month follow up	Central Venous Catheter (CVC) failure/complications (catheter removal due to infection, occlusion and other complications)
Health-related quality of life scores	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
Antibiotic Use	12 months with 3 month follow up	Antibiotic use (starts due to CLABSI, duration)

Trial Locations

Locations (1)

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia