Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- NA
Study ID
NCT07019610
Intervention or treatment
DEVICE: ClearGuard HD
DEVICE: B Braun Combi-stopper
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
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal Brisbane and Women's Hospital
Select from list below to view details:
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
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Who is running the clinical trial?
The University of Queensland
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Control
| Device: B Braun Combi-stopper |
EXPERIMENTAL: Intervention
| Device: ClearGuard HD |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility | Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion) | 12 Months |
| Recruitment | Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study) | 12 Months |
| Fidelity | Protocol fidelity of study participants (≥80% will receive the allocated intervention) | 12 Months |
| Missing data | Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected). | 12 Months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Central Line Associated Blood Stream Infection (CLABSI) Rates | CLABSIs incidence rates (reported as the CLABSI rate per 1000 central line days, which is calculated by dividing the number of CLABSIs by the number of central line days and multiplying the result by 1000 (CDC, 2024) Hospitalisation days for CLABSI | 12 months with 3 month follow up |
| Catheter Related Infections | Central line related infections, defined as infections other than bloodstream infections caused by a central line insertion/insitu such as local skin infections etc. | 12 months with 3 month follow up |
| Central Venous Catheter (CVC) Failure | Central Venous Catheter (CVC) failure/complications (catheter removal due to infection, occlusion and other complications) | 12 months with 3 month follow up |
| Antibiotic Use | Antibiotic use (starts due to CLABSI, duration) | 12 months with 3 month follow up |
| Health-related quality of life scores | Health-related quality of life scores using EuroQual 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire (see attached User Agreement and EQ-5D-5L Questionnaire | 12 months with 3 month follow up |
References
Clinical Trials Gov: Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled TrialOther trials to consider
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