DEXAMETHASONE PHOSPHATE for Severe burns

Inclusion criteria

• {"criterion_text":"- 18 years old ≤ Age ≤ 80 years old.\n- Total burn surface area ≥ 20%, measured by a trained expert upon admission\n- Invasive mechanical ventilation at the time of inclusion\n- Within 48 hours of the burn injury\n- Informed and signed written consent of the next-of-kin, legal representative (trusteeship, guardianship) or emergency procedure in the absence of a legal representative.\n- Affiliation with French social security system or beneficiary from such system"}

Exclusion criteria

• {"criterion_text":"- Imminent death and a do-not-resuscitate order\n- Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women\n- Participation to another interventional study\n- Uncontrolled viral hepatitis or invasive fungal infection\n- Prolonged administration of steroids in the last 90 days (>0.3 mg/kg/day of equivalent prednisolone)\n- Moderate-to-severe ARDS upon admission (according to Berlin definition criteria)\n- Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients"}

Primary endpoints

• {"endpoint_text":"- Major complications defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days\n- All-cause mortality at day 90","definition_or_measurement_approach":"Major complications: defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days. All-cause mortality: measured at day 90. On the basis of a hierarchical testing plan, the primary endpoints will be tested sequentially for superiority (first major complications, if positive then all-cause mortality)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Hospital-acquired infections assessed within 28 days; pneumonia defined using IDSA/ATS joint definition; other infections including skin infections confirmed by independent adjudication committee; antibiotic-free days measured on day 28."}
• {"endpoint_text":"- Respiratory complications: ● ARDS (using Berlin Criteria definition) on day 28 ● Invasive ventilator-free days on day 28","definition_or_measurement_approach":"ARDS defined using Berlin Criteria on day 28; invasive ventilator-free days measured on day 28."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"ICU and hospital length-of-stay recorded; SOFA scores collected on days 1, 3, 7, 14; KDIGO stages 2 and 3 AKI assessed within 28 days."}
• {"endpoint_text":"- General tolerance within day 28: ● hyperglycemia, ● hypernatremia, ● hypokalaemia, ● gastrointestinal bleeding, ● acquired-weakness","definition_or_measurement_approach":"General tolerance/events monitored within 28 days including hyperglycemia, hypernatremia, hypokalaemia, gastrointestinal bleeding, acquired weakness."}
• {"endpoint_text":"- Specific tolerance within 28 days: ● surgical site infections confirmed by an independent adjudication committee, ● autograft failures","definition_or_measurement_approach":"Specific tolerance assessed within 28 days; surgical site infections confirmed by independent adjudication committee; autograft failures recorded."}
• {"endpoint_text":"- Serum CRP levels on day 0, day 1, day 3, day 7 and day 14","definition_or_measurement_approach":"Serum CRP measured at days 0, 1, 3, 7, and 14."}
• {"endpoint_text":"- Timing of first surgery","definition_or_measurement_approach":"Timing of the first surgical intervention recorded."}

France

Earliest CTIS Part Ii Submission Date

10-03-2025

Latest Decision Or Authorization Date

18-04-2025

Processing Time Days

39

Number Of Sites

10

Number Of Participants

478

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France