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NCT Number: NCT06968559

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Tours, Chambray-lès-Tours, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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;

Placebo

Drug

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

Primary outcomes

  1. Major complications

    Time frame: 28 days

    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

  2. All-cause mortality at day 90

    Time frame: 90 days

Secondary outcomes

  1. Hospital-acquired infections

    Time frame: 28 days

    Hospital-acquired pneumonia (using the joint definition from the Infectious Diseases Society of America and American Thoracic Society) within 28 days

  2. Hospital-acquired infections

    Time frame: 28 days

    Catheter-related bloodstream infections within 28 daysDiseases Society of America and American Thoracic Society) within 28 days

  3. Hospital-acquired infections

    Time frame: 28 days

    other infections, including skin infections (diagnosis confirmed by an independent adjudication committee) with or without bacteraemia within 28 days

  4. Hospital-acquired infections

    Time frame: 28 days

    Antibiotic-free days on day 28

  5. Respiratory complications

    Time frame: 28 days

    ARDS (using Berlin Criteria definition) on day 28

  6. Respiratory complications

    Time frame: 28 days

    Invasive ventilator-free days on day 28

  7. ICU Length-of-Stay

    Time frame: 28 days

    ICU Length-of-Stay

  8. Hospital Length-of-Stay

    Time frame: 28 days

    Hospital Length-of-Stay

  9. risks of organ dysfunction

    Time frame: 14 days

    SOFA scores

  10. risks of organ dysfunction

    Time frame: 28 days

    KDIGO stages 2 and 3 AKI

  11. General tolerance of the treatment

    Time frame: 28 days

    Number of Participants with Hyperglycemia

  12. specific tolerance of the treatment on skin lesions

    Time frame: 28 days

    surgical site infections confirmed by an independent adjudication committee,

  13. Timing of first surgery

    Time frame: 28 days

    Timing of first surgery on the main endpoint

  14. Impact of treatment on serum CRP Levels

    Time frame: 14 days

    Serum CRP levels on day 0, day 1, day 3, day 7 and day 14

  15. General tolerance of the treatment

    Time frame: 28 days

    Number of Participants with hypernatremia

  16. General tolerance of the treatment

    Time frame: 28 days

    Number of Participants with hypokalaemia

  17. General tolerance of the treatment

    Time frame: 28 days

    Number of Participants with gastrointestinal bleeding

  18. General tolerance of the treatment

    Time frame: 28 days

    Number of Participants with acquired-weakness

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre BOURDIOL, PH

CONTACT

[email protected]

+33 (0)2 53 482 217

Karim ASHENOUNE, MD, PhD

CONTACT

[email protected]

+33 (0)2 53 482 835

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: DEXA-BURN

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 13, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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