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Study on Glucose Use in Adults with Severe Burns

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Glucose Solution – This medication is administered intravenously, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its role in managing severe burns, specifically focusing on the distribution volume of glucose in the body. The main therapeutic indication is to support metabolic needs and fluid balance in patients with severe burns. At the molecular level, glucose provides energy to cells and helps maintain normal cellular function. It is classified pharmacologically as a carbohydrate and is essential for energy production in the body.

Investigated diseases

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 detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513874-23-00Protocol code2023-03-CHRMTEstimated enrolment15 patientsSponsorCentre Hospital Region Metz Thionville

sourced from the EU Clinical Trials Register and site verification

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