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| Name | Class |
|---|---|
| Royal Brisbane and Women's Hospital | OTHER_GOV |
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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:
Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub:
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.
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 ClearGuardâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard Non-Antimicrobial Hemodialysis Cap |
|
| Intervention | Experimental | Antimicrobial Haemodialysis Catheter Luer End Cap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearGuard HD | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jue (Jenny) Wang | Contact | +61 450 184 498 | jue.wang@health.qld.gov.au |
| Name | Affiliation | Role |
|---|---|---|
| Claire Rickard | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
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A single-centre, two-arm, parallel group randomised controlled trial.
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|
| B Braun Combi-stopper | Device | Standard practice caps used within the Metro North Kidney Health Service |
|
|
| 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 |
| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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