Effect of early dexamethasone on major complications and all-cause mortality in severe burns (DEXA-BURN): A multicenter, randomized, placebo-controlled, double-blind trial

Background Severe burns lead to intense and prolonged systemic inflammation and high rates of organ failure and major complications such as acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) and mortality. Although corticosteroids have shown benefits in various critical care settings, no adequately powered randomized controlled trial has yet evaluated their effect in burn patients. Objectives The DEXA-BURN trial aims to assess whether early administration of dexamethasone reduces the incidence of major complications (moderate-to-severe ARDS or stage 2-3 AKI) and all-cause mortality in adults with severe burns. Methods DEXA-BURN is a multicenter, randomized, placebo-controlled, double-blind trial conducted in 10 French intensive care units. Adult patients with ≥20% total body surface area (TBSA) burns, admitted within 24 hours of injury and requiring mechanical ventilation, will be randomized (1:1) to receive either dexamethasone (0.2 mg/kg/day IV for 5 days) or placebo. The hierarchical primary endpoint includes: (1) major complications within 28 days (moderate to severe ARDS or AKI stage 2–3); and, if positive, (2) all-cause mortality at Day 90. Secondary endpoints include nosocomial infections, ventilator-free days, ICU/hospital stay, CRP trajectory, and steroid-related adverse events. A total of 478 patients will be enrolled. Analyses will follow the ITT and mITT principle. Discussion This trial will provide for the first time high-quality evidence on the effectiveness and safety of corticosteroid therapy in the acute management of severely burned patients. Findings may inform future guidelines and improve critical care practices for this understudied population with a high-risk of mortality. Trial registration: EudraCT: 2024-517708-12-00; ClinicalTrials.gov: NCT06968559