Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ClearGuard HD, B Braun Combi-stopper.
- Who it may be relevant to
- Registry conditions: Vascular Access Complication, Device Related Infection, Device Related Sepsis, Catheter Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial
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.
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.
Interventions
- 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
Primary outcome measures
- Eligibility [Time frame: 12 Months]
- Recruitment [Time frame: 12 Months]
- Fidelity [Time frame: 12 Months]
- Missing data [Time frame: 12 Months]
Secondary outcome measures (5)
- Central Line Associated Blood Stream Infection (CLABSI) Rates [Time frame: 12 months with 3 month follow up]
- Catheter Related Infections [Time frame: 12 months with 3 month follow up]
- Central Venous Catheter (CVC) Failure [Time frame: 12 months with 3 month follow up]
- Antibiotic Use [Time frame: 12 months with 3 month follow up]
- Health-related quality of life scores [Time frame: 12 months with 3 month follow up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Australia · 1 center
- Royal Brisbane and Women's Hospital — Herston
Identifiers
NCT: NCT07019610 · IVPA_25.01