Study on Glucose Use in Adults with Severe Burns

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What is this study about?

This clinical trial focuses on patients with severe burns. The study aims to understand how the body distributes glucose during the first four days of treatment for adults who have experienced severe burns. The treatment involves using an injectable solution called GLUCOSE 30% PROAMP, which is administered through an IV injection or infusion. The purpose of the study is to describe the average initial volume of glucose distribution in these patients.

Participants in the study will receive the glucose solution, and their blood glucose levels will be measured at specific times to observe how the glucose is distributed in the body. This involves taking a blood sample, injecting a small amount of glucose, and then measuring the blood glucose level again after a short period. The study will also monitor other factors such as the volume of blood in the chest and the amount of water in the lungs, using a special device called PiCCO.

The study will last for four days, during which various measurements will be taken to gather information about the body’s response to the glucose treatment. The goal is to improve understanding of how glucose is distributed in patients with severe burns, which may help in managing their treatment more effectively in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is over 18 years old, has burns covering at least 30% of the body surface area, and was admitted within 8 hours post-burn.

Consent is required, either directly from the patient or from a trusted person if the patient is unable to provide it.

2 glucose administration

A solution called glucose 30% proamp is administered. This is a solution for injection given through an intravenous (IV) line.

A bolus of 5 grams of glucose is injected into a central venous line over 30 seconds.

3 blood glucose measurement

A reference blood glucose level is measured using an arterial blood sample taken from an arterial catheter.

Three minutes after the glucose injection, a second blood glucose level is measured. The difference between these two levels is recorded.

4 calculation of initial distribution volume of glucose (IDVG)

The IDVG is calculated using a specific formula: IDVG = 24.4 x e(-0.0298 * d[glu]) + 2.7 in liters, where d[glu] is the difference in blood glucose levels measured in mg/dl.

5 additional measurements

At the same time as the IDVG measurement, other parameters are assessed, including intra-thoracic blood volume (ITBV) and extra-vascular lung water (EVLW) using a device called PiCCO.

Body surface area is assessed using the Wallace method, and water intake and output balance are monitored.

6 monitoring and follow-up

The primary objective is to describe the mean values of the initial volume of glucose distribution during the first four days of management.

Secondary endpoints include monitoring in-hospital mortality and arterial blood glucose levels before and after glucose bolus injection.

Who Can Join the Study?

Patients must be over 18 years old.
Patients must be hospitalized with burns covering at least 30% of their body surface. This means a large part of their skin is affected by the burn.
The burns must be caused by heat, such as fire or hot liquids.
Patients must be treated at the CHR Metz-Thionville burn center within 8 hours after the burn injury.
Patients must be part of a social security scheme, which is a system that provides health coverage.
Written consent must be obtained from the patient. If the patient cannot give consent, a trusted person, family member, or relative can provide it. If no one is available, emergency inclusion is possible.

Who Cannot Join the Study?

Patients who do not have severe burns cannot participate. Severe burns are serious injuries to the skin caused by heat, chemicals, electricity, or radiation.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Patients who are not male or female cannot participate. The study includes both men and women.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospital Region Metz Thionville	Metz	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Glucose

Glucose is used in this trial to study how it is distributed in the body of severely burned adults during the first four days of treatment. The focus is on understanding the initial volume of glucose distribution, which can help in managing the patient’s condition effectively.

Investigated diseases:

Thermal burn

Severe burns – Severe burns are injuries to the skin and underlying tissues caused by heat, chemicals, electricity, or radiation. They can damage multiple layers of skin and may extend to muscles and bones. The severity of a burn is determined by its depth and the percentage of body surface area affected. Severe burns can lead to significant fluid loss, infection, and complications affecting other organs. The healing process can be prolonged and may result in scarring and loss of function in the affected areas. Management often involves specialized care to support healing and prevent complications.

Trial ID:

2024-513874-23-00

Protocol code:

2023-03-CHRMT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Glucose Use in Adults with Severe Burns

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