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Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns

RecruitingPhase 3Ages 18 Years - 80 YearsAllNantes University Hospital
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In plain words

What the trial is, and whether it could suit you

Burns affect more than 11 million people worldwide each year. These injuries are responsible for severe morbidity resulting in a high societal burden and account for more than 180,000 yearly deaths especially in low- and middle-income countries. Major burns induce an important local and systemic inflammatory response that may be overwhelmed. This inflammation is a physiological phenomenon that favours the healing of tissues. However, the overproduction of inflammatory mediators might lead to an exacerbated Systemic Inflammatory Response Syndrome (SIRS). Recently the total body surface area (TBSA) burned has shown to be well correlated to persistent elevation of pro-inflammatory mediators (such as IL-6). This SIRS, in turn, contributes to the enhanced risk of sepsis, acute respiratory distress syndromes (ARDS) and organ failures in general such as acute kidney injuries (AKI), most of tho

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years old ≤ Age ≤ 80 years old. * Total burn surface area ≥ 20%, measured by a trained expert upon admission * Invasive mechanical ventilation at the time of inclusion * Within 48 hours of the burn injury * Informed and signed written consent of the next-of-kin, legal representative (trusteeship, guardianship) or emergency procedure in the absence of a legal representative. * Affiliation with French social security system or beneficiary from such system Exclusion Criteria: * Imminent death and a do-not-resuscitate order * Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients * Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women * Participation to another interventional study involving a drug with known interactions with dexamethasone * Uncontrolled viral hepatitis or invasive fungal infection at the time of inclusion * Prolonged administration of steroids in the last 90 days (\>0.3 mg/kg/day of equivalent prednisolone) * Moderate-to-severe ARDS upon admission (according to Berlin definition criteria)
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What it tests

  • Dexamethasone
  • Placebo
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Where

10 sites
CHU Tours
Chambray-lès-Tours, France
CHU Lille
Lille, France
CHU de Lyon
Lyon, France
Aphm Hopital La Timone
Marseille, France
CHR Metz
Metz, France
CHU Montpellier
Montpellier, France
Chu Nantes
Nantes, France
HU Saint-Louis Lariboisière
Paris, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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