Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial (ECHO-HD)

The University of Queensland

Status: Not yet enrolling

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

Treatments: Device: ClearGuard HD; Device: B Braun Combi-stopper

Study type: Interventional

Funder types: Other

Identifiers

NCT07019610

IVPA_25.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard Non-Antimicrobial Hemodialysis Cap

Treatment:

Device: B Braun Combi-stopper

Intervention

Experimental group

Description:

Antimicrobial Haemodialysis Catheter Luer End Cap

Treatment:

Device: ClearGuard HD