Clinical trial NCT07019610: Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
Official title: Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
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
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Royal Brisbane and Women's Hospital
First posted: 2025-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre, two-arm, parallel group randomised controlled trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eligibility
timeFrame: 12 Months
measure: Recruitment
timeFrame: 12 Months
measure: Fidelity
timeFrame: 12 Months
measure: Missing data
timeFrame: 12 Months
Secondary outcomes:
measure: Central Line Associated Blood Stream Infection (CLABSI) Rates
timeFrame: 12 months with 3 month follow up
measure: Catheter Related Infections
timeFrame: 12 months with 3 month follow up
measure: Central Venous Catheter (CVC) Failure
timeFrame: 12 months with 3 month follow up
measure: Antibiotic Use
timeFrame: 12 months with 3 month follow up
measure: Health-related quality of life scores
timeFrame: 12 months with 3 month follow up
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Claire Rickard
role: PRINCIPAL_INVESTIGATOR
References: