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Study of dexamethasone effectiveness in reducing complications and mortality in patients with severe burns

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What is this trial about?

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

This study focuses on patients with severe burns affecting a large portion of the body surface. The research examines the effects of dexamethasone phosphate, a medication given through an intravenous line, along with sodium chloride solution. The purpose is to determine if dexamethasone can reduce serious complications and death rates in people with severe burn injuries.

The treatment involves receiving dexamethasone through a vein within the first two days after the burn injury occurs. The medication will be given for up to 5 days while patients are in the hospital under close medical supervision. During this time, patients will also receive standard burn care and treatment.

Throughout the study, doctors will monitor patients for various health issues that can occur after severe burns, including breathing problems and kidney function. They will also track other complications such as infections and wound healing. Patients will be followed for up to 90 days to assess their recovery and overall health outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and admission

    Your eligibility for the study will be evaluated within 48 hours after burn injury

    You must be between 18 and 80 years old with burn injuries covering at least 20% of body surface

    You will need to be on breathing support (mechanical ventilation) at the time of inclusion

  2. Step 2

    Treatment administration

    You will receive either dexamethasone phosphate or sodium chloride through an intravenous line

    The medication will be administered directly into your bloodstream

  3. Step 3

    Monitoring period - first 14 days

    Your blood will be tested on days 0, 1, 3, 7, and 14 to measure inflammation levels

    Your organ function will be assessed on days 1, 3, 7, and 14

    Your blood sugar, salt levels, and potassium levels will be regularly monitored

  4. Step 4

    28-day observation period

    Your breathing function will be monitored for potential breathing difficulties

    Your kidney function will be checked regularly

    You will be monitored for any infections, including pneumonia and blood infections

    The success of skin grafts and healing of surgical sites will be evaluated

  5. Step 5

    Extended follow-up

    Your health status will be monitored for up to 90 days

    The length of your stay in intensive care and hospital will be recorded

    Any complications or health issues during this period will be documented

Who can join the trial?

6 criteria

  • Age between 18 and 80 years old
  • Have burns covering at least 20% of total body surface (as measured by a medical expert when admitted to hospital)
  • Be on invasive mechanical ventilation (using a breathing machine through a tube placed in the windpipe) at the time of joining the study
  • Be within 48 hours (2 days) after experiencing the burn injury
  • Have written consent from next-of-kin or legal representative. In emergency situations where no legal representative is available, a special emergency procedure may be used
  • Be affiliated with or be a beneficiary of the French social security system

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Patients with active infections (ongoing infections that require treatment)
  • History of allergic reactions to dexamethasone or similar medications
  • Current use of other corticosteroid medications (medications similar to dexamethasone)
  • Patients with diabetes that is not well controlled
  • Severe heart, liver, or kidney disease
  • Burns older than 48 hours at the time of admission
  • Patients with immunosuppression (weakened immune system)
  • Mental conditions that prevent giving informed consent
  • Participation in other clinical trials within the past 30 days
  • Burns caused by chemical or electrical injuries
  • Gastrointestinal ulcers (open sores in stomach or intestines)
  • Severe psychiatric disorders
  • Current treatment with medications that may interact with dexamethasone
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Investigated drugs

Dexamethasone is a steroid medication that helps reduce inflammation in the body. In burn patients, it works by decreasing the body's immune response to reduce swelling, pain, and other complications that can occur after severe burns. This medication can help prevent serious complications and improve survival rates in patients with severe burns. It is typically given through an intravenous (IV) line directly into the bloodstream to ensure quick action when treating severe burn injuries.

What is already known about the treatment

Dexamethasone - A synthetic corticosteroid medication administered orally, intravenously, or topically, which has been well-established in medical practice for decades. This powerful anti-inflammatory drug is commonly used in treating severe burns and other conditions where inflammation control is crucial, working by suppressing the immune system's response and reducing inflammation at the molecular level by inhibiting the production of inflammatory mediators. As a glucocorticoid class medication, dexamethasone acts by binding to specific nuclear receptors to regulate gene expression, leading to decreased inflammation, reduced swelling, and modulated immune response, making it particularly valuable in managing severe burn cases where excessive inflammatory response can cause additional complications.

Investigated diseases

  • Severe Burns

    A serious injury to the skin and underlying tissues caused by heat, chemicals, electricity, or radiation. Burns are classified by their depth and extent of body surface area affected, with severe burns involving deeper layers of tissue and covering larger portions of the body. These injuries cause immediate cell death in the affected areas, followed by an inflammatory response throughout the body. Severe burns can lead to fluid loss, difficulty regulating body temperature, and changes in bodily functions. The healing process involves the formation of new skin tissue and may result in scarring.

  • Acute Respiratory Distress Syndrome (ARDS)

    A serious lung condition where fluid builds up in the tiny air sacs (alveoli) in the lungs. This fluid prevents the lungs from filling with enough air, resulting in less oxygen reaching the bloodstream. The condition develops rapidly and makes breathing increasingly difficult. ARDS typically occurs as a complication of another severe illness or injury.

  • Acute Kidney Injury (AKI)

    A sudden decrease in kidney function that develops within a few hours or days. This condition causes a build-up of waste products in the blood and makes it difficult for the kidneys to maintain the correct balance of body fluids. AKI can affect other organs and body systems as toxins and excess fluid accumulate.

  • Hospital-Acquired Pneumonia

    A lung infection that develops during a hospital stay, typically 48 hours or more after admission. The infection causes inflammation in the lungs' air sacs, leading to breathing difficulties and other respiratory symptoms. This condition often affects people who are already hospitalized for other conditions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517708-12-00Protocol codeRC24_0442Estimated enrolment478 patientsSponsorCentre Hospitalier Universitaire De Nantes

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