Early dexamethasone to lower complications and death after severe burns

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

This test gives early dexamethasone or placebo to adults with severe burns who are on mechanical ventilation to see if it reduces major complications and death.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 10 sites (Chambray-lès-Tours and 9 other locations)
• Trial ID: NCT06968559 on ClinicalTrials.gov

What this trial studies

This is a Phase 3 randomized, placebo-controlled study comparing early dexamethasone to placebo in adults with severe burns (≥20% total body surface area) who require invasive mechanical ventilation within 48 hours of injury. Participants are randomized to receive dexamethasone or placebo and are monitored for major complications such as sepsis, ARDS, acute kidney injury, and all-cause mortality, with particular attention to events occurring in the first week. The trial is led by Nantes University Hospital with sites in Tours, Lille, and Lyon and uses next-of-kin or legal-representative consent where needed. Eligible patients must be 18–80 years old and affiliated with the French social security system.

Who should consider this trial

Good fit: Adults aged 18–80 with burns affecting at least 20% of total body surface area who require invasive mechanical ventilation within 48 hours of the injury and who meet French social-security and consent requirements are ideal candidates.

Not a fit: Patients with imminent death or do-not-resuscitate orders, known dexamethasone allergy, pregnancy or breastfeeding, uncontrolled viral hepatitis or invasive fungal infection, or those already on prolonged corticosteroids are unlikely to benefit.

Why it matters

Potential benefit: If successful, early dexamethasone could reduce the risk of sepsis, organ failure, and death after major burns.

How similar studies have performed: Corticosteroids have shown benefit in other acute inflammatory settings such as septic shock and ARDS, but their role in preventing early complications specifically after major burns is not yet well established.

Eligibility criteria

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)

Where this trial is running

Chambray-lès-Tours and 9 other locations

• CHU Tours — Chambray-lès-Tours, France (Not_yet_recruiting)
• CHU Lille — Lille, France (Not_yet_recruiting)
• CHU de Lyon — Lyon, France (Not_yet_recruiting)
• Aphm Hopital La Timone — Marseille, France (Not_yet_recruiting)
• CHR Metz — Metz, France (Not_yet_recruiting)
• CHU Montpellier — Montpellier, France (Not_yet_recruiting)
• Chu Nantes — Nantes, France (Recruiting)
• HU Saint-Louis Lariboisière — Paris, France (Not_yet_recruiting)
• CHU Bordeaux — Pessac, France (Not_yet_recruiting)
• CHU Toulouse — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Karim ASHENOUNE, MD, PhD

Conditions Severe Burns