NCT07019610

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

Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-02-01
• First posted: 2025-06-13
• Last updated: 2026-02-27

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study