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

NCT06968559 | Recruiting Phase 3

• 2 other identifiers: RC24_04422024-517708-12-00
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 10

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 especially in low- and middle-income countries. Major burns induce an important local and systemic inflammatory response that may be overwhelmed. This inflammation is a physiological phenomenon that favours the healing of tissues. However, the overproduction of inflammatory mediators might lead to an exacerbated Systemic Inflammatory Response Syndrome (SIRS). Recently the total body surface area (TBSA) burned has shown to be well correlated to persistent elevation of pro-inflammatory mediators (such as IL-6). This SIRS, in turn, contributes to the enhanced risk of sepsis, acute respiratory distress syndromes (ARDS) and organ failures in general such as acute kidney injuries (AKI), most of those occurring within the first week of admission. Corticosteroids (CS) have already proven their effectiveness against SIRS-induced organ dysfunction or mortality in acute medicine notably in septic shock, polytraumatized patients and more recently in the treatment of viral or non-viral ARDS without increasing the risk of secondary bacterial complications or significant side effects . Indeed the recent SCCM Guidelines clearly advocate for the use of CS in severe community-acquired pneumonia, septic shock and ARDS. The investigators recently performed a large multicenter, double-blinded randomized controlled trial (the PACMAN trial, PHRC-N 2016) including 1222 patients scheduled for major surgery in which the investigators observed a major decrease in CRP blood concentrations in the dexamethasone arm. The rate of AKI and the need for mechanical ventilation were also significantly reduced in the intervention arm. ICU Patients with severe burns undergo several surgeries, including major procedures (excision, skin grafts), rendering them quite similar to those in the PACMAN trial in terms of inflammatory response. Very few side effects (hyperglycemia mainly) easily overcome in ICU are usually reported with the use of low-to-moderate dose of CS. In severe burn patients, very few data are available to date, two retrospective case control studies and a small prospective randomized trial showed promising results when using CS but high quality evidence is lacking. The investigators hypothesise here that the use of dexamethasone after major burns, the prototypic model of inflammatory response in surgical ICU patients, would limit SIRS-induced organ failure and/or all-cause mortality.

Conditions

Severe Burns

Outcome Measures

Primary Outcomes (2)

• Major complications

  It's a hierarchic procedure. Major complications defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days

  28 days

• All-cause mortality at day 90

  90 days

Secondary Outcomes (18)

• Hospital-acquired infections

  28 days

• Hospital-acquired infections

  28 days

• Hospital-acquired infections

  28 days

• Hospital-acquired infections

  28 days

• Respiratory complications

  28 days

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 0.2 mg/kg of ideal body weight (IBW) IV (at a maximum of 20 mg per day) will be blindly infused from day 1 to day 5

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo: one IV administration per day from day 1 to day 5.

Drug: Placebo

Interventions

Dexamethasone DRUG

Dexamethasone 0.2 mg/kg of ideal body weight (IBW) IV (at a maximum of 20 mg per day) will be blindly infused from day 1 to day 5;

Dexamethasone

Placebo DRUG

Placebo: one IV administration per day from day 1 to day 5.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ Age ≤ 80 years old.
• Total burn surface area ≥ 20%, measured by a trained expert upon admission
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (10)

CHU Tours

Chambray-lès-Tours, 37170, France

NOT YET RECRUITING

CHU Lille

Lille, 59037, France

NOT YET RECRUITING

CHU de Lyon

Lyon, 69437, France

NOT YET RECRUITING

Aphm Hopital La Timone

Marseille, 13005, France

NOT YET RECRUITING

CHR Metz

Metz, 57085, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

Chu Nantes

Nantes, 44093, France

RECRUITING

HU Saint-Louis Lariboisière

Paris, 75475, France

NOT YET RECRUITING

CHU Bordeaux

Pessac, 33604, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Karim ASHENOUNE, MD, PhD

CONTACT

+33 (0)2 53 482 835; karim.asehnoune@chu-nantes.fr

Alexandre BOURDIOL, PH

CONTACT

+33 (0)2 53 482 217; alexandre.bourdiol@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): February 7, 2029
• Study Completion (Estimated): February 7, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)