Status:
RECRUITING
Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns
Lead Sponsor:
Nantes University Hospital
Conditions:
Severe Burns
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 es...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 7 2029
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT06968559
Start Date
November 7 2025
End Date
February 7 2029
Last Update
November 18 2025
Active Locations (10)
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1
CHU Tours
Chambray-lès-Tours, France, 37170
2
CHU Lille
Lille, France, 59037
3
CHU de Lyon
Lyon, France, 69437
4
Aphm Hopital La Timone
Marseille, France, 13005