Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
No applicable phase (e.g. observational)
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
Sponsor: The University of Queensland
trial.available_in:
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Overview
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.
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.
Who can participate
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