RecruitingPHASE2INTERVENTIONAL

Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults

This study, taking place at CHR Metz-Thionville, focuses on adults with severe burns during their initial four days in intensive care. When someone has severe burns, their body can leak a lot of fluid, leading to problems. Doctors currently try to replace these fluids carefully, but it's a balancing act – too little can be dangerous, and so can too much. This research uses a special way to measure the fluid around cells (called 'extracellular fluid') by giving a small amount of glucose (sugar) solution. By tracking these fluid levels, the study aims to help doctors understand how fluid changes in burn patients. This understanding could lead to better ways of giving fluids and ultimately improve recovery for people with severe burns.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrolment target

Start

28 Nov 2024

Estimated completion

28 Mar 2027

Burns Intensive Care Emergencies

What is this study about?

When someone has very severe burns, their body reacts strongly. One major problem is that blood vessels can become leaky, causing a lot of fluid to escape into the surrounding tissues. This is a big challenge for doctors because they need to give patients enough fluids to keep their body working, but not too much, which can also cause serious problems like difficulty breathing or heart issues.

Currently, doctors use formulas and regularly check a patient's condition to decide how much fluid to give. However, it's a complex balancing act, and they believe there could be better, more precise ways. This study wants to explore a new method to help with this. It uses a very accurate way to measure the amount of fluid outside of cells in the body, which is where a lot of the leaked fluid goes. They call this the 'initial volume of glucose distribution' (IDVG).

The study involves giving a small amount of special glucose (sugar) solution through a drip. They can then see how this glucose spreads throughout the body's fluids. Because glucose spreads quickly into the fluid around the cells, measuring it helps doctors understand how much of this 'extracellular fluid' there is. By tracking these measurements over the first few days, the researchers hope to get a clearer picture of how fluid levels change in severely burned patients. This knowledge could really help doctors make better decisions about how much fluid to give, leading to improved care and recovery for patients.

Key takeaways

This study helps doctors understand how fluid levels change in severe burn patients.
It uses a special glucose solution to better measure the fluid around cells.
The goal is improved fluid management for future burn patients.
Participation involves extra monitoring during the first four days of intensive care.
It's an observational study, meaning no new treatments are being tested.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults aged 18 or older who have been admitted to the CHR Metz-Thionville burn centre with severe burns covering at least 30% of their body, caused by heat. They must have been admitted within 8 hours of their burn. You'd also need to be covered by a social security scheme. If you're able to, you would need to give your written permission to take part. If you're not able to, a trusted person or family member could give permission for you. If no one is available in an emergency, you might still be included immediately.

There are several reasons why someone might not be able to join the study. For example, if you have diabetes and use insulin, or if you have a known allergy or medical reason not to have the specific glucose solution used in the study. You also wouldn't be able to participate if you've recently had a cardiac arrest, or if you're on certain types of life support machines, or if you don't have certain medical lines (like a central venous line).

The study also cannot include pregnant or breastfeeding women, people who are under legal guardianship, or those with severe memory problems or a language barrier that would prevent them from understanding the study. If you are extremely unwell and facing immediate limits on your treatment, or if it's not possible to perform certain monitoring procedures, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you admitted to CHR Metz-Thionville burn centre for severe burns (at least 30% of your body)?
Were your burns caused by heat, and were you admitted within 8 hours of the burn?
Do you *not* have diabetes that requires insulin?
Are you *not* pregnant or breastfeeding?
Do you *not* have a known allergy to glucose solution?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will monitor your fluid levels using a special method. This involves giving you a small amount of a specific glucose (sugar) solution through an existing intravenous drip. They will then take blood samples at set times to measure how the glucose is distributed in your body. This will help them understand how your body's fluid levels are changing. You will continue to receive your usual intensive care for your burns. The study observations will take place during your first four days in intensive care. There are no additional visits required beyond your existing hospital stay. You have the right to withdraw from the study at any time without affecting your medical care.

Potential risks and benefits

The potential benefit of taking part is that the information gathered could help doctors understand how to better manage fluids in severe burn patients in the future, potentially improving care for others. As this is an observational study, it primarily involves monitoring and does not involve new treatments beyond your standard care, so the direct medical risks are generally low. However, you will have additional blood samples taken and receive a glucose solution, which carries minimal risks, like discomfort from needle insertion or, very rarely, a reaction to the glucose. You have the right to withdraw from the study at any time without needing to give a reason, and this will not affect the medical care you receive.

Locations (1)

CHR Metz-Thionville/Hopital de Mercy
Verified postcode
Metz, France· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand how fluid levels around cells change in severely burned adults during their first few days in intensive care, to help doctors give the right amount of fluids.

What is 'Extracellular Fluid Volume' (ECFV)?

ECFV is simply the amount of fluid that is outside of your body's cells, including the fluid in your blood and the fluid surrounding your tissues.

How will you measure my fluid levels?

Doctors will give you a small, safe amount of a glucose (sugar) solution through a drip and then take blood samples to see how it spreads throughout your body's fluids.

Will I receive a new treatment in this study?

No, this is an 'observational' study. You will continue to receive standard intensive care for your burns. The study is about monitoring and understanding, not testing new treatments.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, and it will not affect the medical care you receive for your burns.

How to find out more

Arpiné EL NAR, PhD

projet-recherche-clinique@chr-metz-thionville.fr 0033387557766 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.