Effect of early dexamethasone on major complications and all-cause mortality in severe burns

Severe burns

Hierarchical endpoints: - Major complications defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days - All-cause mortality at day 90 On the basis of a hierarchical testing plan, the primary endpoints will be tested sequentially for superiority. First we will test for superiority on major complications. If positive, we will test for superiority on all-cause mortality.

Hospital-acquired infections: ● Hospital-acquired pneumonia (using the joint definition from the Infectious Diseases Society of America and American Thoracic Society) within 28 days ● Catheter-related bloodstream infections within 28 days ● other infections, including skin infections (diagnosis confirmed by an independent adjudication committee) with or without bacteraemia within 28 days ● Antibiotic-free days on day 28, Respiratory complications: ● ARDS (using Berlin Criteria definition) on day 28 ● Invasive ventilator-free days on day 28, ICU LOS and Hospital LOS, SOFA scores on day 1, day 3, day 7 and day 14, KDIGO stages 2 and 3 AKI within 28 days, General tolerance within day 28: ● hyperglycemia, ● hypernatremia, ● hypokalaemia, ● gastrointestinal bleeding, ● acquired-weakness, Specific tolerance within 28 days: ● surgical site infections confirmed by an independent adjudication committee, ● autograft failures, Serum CRP levels on day 0, day 1, day 3, day 7 and day 14, Timing of first surgery

France