IVCare is a clinical trial designed to identify the most effective interventions to prevent infections and other complications arising from central venous access devices.
About
Central venous access devices (CVADs) are tubes inserted into large veins to deliver treatments such as chemotherapy or dialysis. Although vital for care, they carry a risk of complications. One of the most serious is a central line–associated bloodstream infection (CLABSI), which occurs when bacteria enter the bloodstream during line use or care.
Other potential issues include the device becoming dislodged or the formation of blood clots. These complications can result in longer hospital stays, increased costs, and potentially life-threatening illness.
A variety of devices and care approaches are used to minimise these risks, including skin antiseptics, dressings, securement devices, connectors, and antimicrobial locking solutions. These are applied across diverse patient groups, such as those undergoing cancer treatment, dialysis, or intensive care. However, it remains unclear which strategies are most effective overall, or for specific patient populations.
The IVCare trial addresses this by evaluating multiple aspects of CVAD care within a single, large clinical trial. Interventions are grouped into “domains” (for example, securement devices or connectors), with each domain comparing different options to identify the most effective approach. The trial is designed to evolve over time, allowing new treatments and technologies to be included as they emerge.
The findings will support clinicians, healthcare services, and patients in choosing safer, more effective ways to manage CVADs.
Trial Sponsor
The University of Queensland
Coordinating investigators
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Global Steering Committee
- Professor Claire Rickard (Co-chair)
- Associate Professor Andrew Stewardson (Co-chair)
- Associate Professor Jessica Schults
- Professor Steven Tong
- Professor Joshua Byrnes
- Professor Zoe McQuilten
- Professor James McGree
- Adjunct Professor Kevan Polkinghorne
- Dr Benjamin Lazarus
- Dr Aleece MacPhail
- Professor Thomas Snelling
- Associate Professor Julie Marsh
- Mr Michael Dymock
- Dr Niccolò Buetti
- Professor Olivier Mimoz
- Dr Bertrand Drugeon
- Mrs Sarah Smith
- Associate Professor Patrick Harris
- Professor David Patterson
- Associate Professor Andrea Henden
- Associate Professor Evan Alexandrou
Patient FAQ
What is the purpose of the IVCare study?
The purpose of the IVCare study is to compare different devices and care strategies used with central venous access devices (CVADs) to find out which approaches are most effective in reducing complications. The study will help improve care for patients who need CVADs in the future.
Who is running the IVCare study?
The IVCare study is being conducted by researchers in Australia and has the potential to include sites in other countries in the future.
The global sponsor for the study is The University of Queensland.
How do I decide if I want to take part in the IVCare study?
Before you decide whether to take part in the IVCare study, a doctor or nurse will explain it to you and give you an information sheet with more details.
All participants take part in an observational study. This means we collect information that is mostly already part of your normal care, along with a few extra questions about you, your device, how it is cared for, and any problems you may experience.
There are also two optional parts of the study (called the Connectors/Caps and Securement domains). You can choose to take part in none, one, or both, depending on your preference and eligibility. If you join one of these optional parts, you will receive either a new device being studied or the standard device used by your hospital. Your doctor or nurse will explain this fully and answer any questions.
Some parts of the study have specific requirements, so you may not be eligible for all of them.
If you decide to participate, you’ll be asked to sign a consent form and will receive a copy to keep. You can leave the study at any time, and this will not affect your care.
What happens when I agree to participate in this study?
After joining the study:
- We'll ask you some questions about your health and medical history
- Your healthcare team will record details about your CVAD
- You'll complete a short questionnaire about your quality of life
For the first four weeks, there will be weekly check-ins to assess:
- Your CVAD
- Whether the intervention or interventions you are assigned to are still being used
- Whether there have been any changes in your health
After the first month, the study team will continue to check in with you regularly for up to 6 months.
During this follow-up period, the study team will record important outcomes such as infections, CVAD removal and safety events. If you experience any complications, the study team at your hospital may contact you during or after the study to ask some additional questions.
At the end of your participation, you will again be asked about your quality of life and your experience of care at the hospital.
You may then choose to re-enrol in the IVCare study, if eligible, or return to the usual devices or care used by your hospital.
How can I get a copy of my signed consent form?
Email us at ivcare@uq.edu.au
Do I have to take part?
No. It is completely your choice whether or not you would like to take part in the study. Your decision will not affect any of the care or treatment you receive while in hospital.
If you decide not to participate in the study, you will be given the standard care and devices used at your hospital to help prevent complications related to your CVAD. These may be the same devices or care strategies used in the IVCare study.
Will it cost me anything to be in this study?
You do not have to pay anything to take part in the study, and you will not be paid for taking part. Any medications, tests, or medical care needed for the IVCare trial will be provided at no cost to you.
What do I do if I have a complaint?
If you have any complaints about the conduct of the study or any member of the study team, you have the right to make a complaint. This will not affect any care or treatment you are receiving.
Please direct all complaints to:
Royal Melbourne Hospital Human Research Ethics Committee
Phone: (03) 9342 8530
Email: research@mh.org.au
Who do I call for information after I leave the hospital?
You will be given a participant card with the study team's contact details to use at any time if you have any questions or concerns.
What is an adaptive clinical trial?
The IVCare trial is an adaptive platform trial. This means the study can learn and make changes as it goes, based on the results collected.
At different points during the trial, the researchers review the data to see which devices or care strategies are most effective and which are less effective.
Participants are randomised to different devices or care strategies, but the trial can adapt over time. Devices or care strategies that are performing better may be assigned to more participants, while less effective options may be used less often. This means that after the study has been running for a while, there may be a greater chance of receiving a device or care strategy that is showing better results in the study.
Adaptive trials are also flexible. Over time, we can test new devices and care strategies as they become available. This helps researchers find more effective ways to prevent central venous access device-related complications more quickly.
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Trial locations
The IVCare trial will soon be recruiting patients from:
Contact
For patients
If you have questions that your hospital team can't answer, or you're experiencing issues with trial surveys or materials, please contact us via email ivcare@uq.edu.au.
For investigators
To join or find out more about the trial, please contact us via email ivcare@uq.edu.au.