Catheter Complications, Catheter Infection, Catheter Related Complications, Catheter-Related Infections, Device Related Infection, Device Related Sepsis, Hemodialysis Catheter-associated Infection, Hemodialysis Catheter Infection, Hemodialysis Complication, Vascular Access Complication
Conditions
Keywords
Hemodialysis Catheter, Randomised Controlled Trial, Antimicrobial Barrier Caps, Vascular access device, Hemodialysis catheter caps, Chlorhexidine cap, Central Venous Catheter, CVC, CLABSI, Central Line Associated Blood Stream Infection
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.
Interventions
DEVICEClearGuard 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.
DEVICEB Braun Combi-stopper
Standard practice caps used within the Metro North Kidney Health Service
Sponsors
The University of Queensland
Royal Brisbane and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single-centre, two-arm, parallel group randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility | 12 Months | Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion) |
| Recruitment | 12 Months | Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study) |
| Fidelity | 12 Months | Protocol fidelity of study participants (≥80% will receive the allocated intervention) |
| Missing data | 12 Months | Missing data for primary outcome (\<5% of primary outcome data will be unable to be collected). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Line Associated Blood Stream Infection (CLABSI) Rates | 12 months with 3 month follow up | 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 |
| Catheter Related Infections | 12 months with 3 month follow up | Central line related infections, defined as infections other than bloodstream infections caused by a central line insertion/insitu such as local skin infections etc. |
| Central Venous Catheter (CVC) Failure | 12 months with 3 month follow up | Central Venous Catheter (CVC) failure/complications (catheter removal due to infection, occlusion and other complications) |
| Antibiotic Use | 12 months with 3 month follow up | Antibiotic use (starts due to CLABSI, duration) |
| Health-related quality of life scores | 12 months with 3 month follow up | 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 |
Countries
Australia
Contacts
CONTACTJue (Jenny) Wang
PRINCIPAL_INVESTIGATORClaire Rickard
The University of Queensland
Outcome results
None listed