Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The University of Queensland
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Eligibility
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Intervention
Antimicrobial Haemodialysis Catheter Luer End Cap
Intervention: ClearGuard HD (Device)
Control
Standard Non-Antimicrobial Hemodialysis Cap
Intervention: B Braun Combi-stopper (Device)
Outcomes
Primary Outcomes
Eligibility
Time Frame: 12 Months
Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion)
Recruitment
Time Frame: 12 Months
Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study)
Fidelity
Time Frame: 12 Months
Protocol fidelity of study participants (≥80% will receive the allocated intervention)
Missing data
Time Frame: 12 Months
Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected).
Secondary Outcomes
- Central Line Associated Blood Stream Infection (CLABSI) Rates(12 months with 3 month follow up)
- Catheter Related Infections(12 months with 3 month follow up)
- Central Venous Catheter (CVC) Failure(12 months with 3 month follow up)
- Antibiotic Use(12 months with 3 month follow up)
- Health-related quality of life scores(12 months with 3 month follow up)