Dexamethasone
DrugDexamethasone 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;
NCT Number: NCT06968559
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 3
CHU Tours, Chambray-lès-Tours, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: one IV administration per day from day 1 to day 5.
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
Time frame: 90 days
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
Time frame: 28 days
Catheter-related bloodstream infections within 28 daysDiseases Society of America and American Thoracic Society) within 28 days
Time frame: 28 days
other infections, including skin infections (diagnosis confirmed by an independent adjudication committee) with or without bacteraemia within 28 days
Time frame: 28 days
Antibiotic-free days on day 28
Time frame: 28 days
ARDS (using Berlin Criteria definition) on day 28
Time frame: 28 days
Invasive ventilator-free days on day 28
Time frame: 28 days
ICU Length-of-Stay
Time frame: 28 days
Hospital Length-of-Stay
Time frame: 14 days
SOFA scores
Time frame: 28 days
KDIGO stages 2 and 3 AKI
Time frame: 28 days
Number of Participants with Hyperglycemia
Time frame: 28 days
surgical site infections confirmed by an independent adjudication committee,
Time frame: 28 days
Timing of first surgery on the main endpoint
Time frame: 14 days
Serum CRP levels on day 0, day 1, day 3, day 7 and day 14
Time frame: 28 days
Number of Participants with hypernatremia
Time frame: 28 days
Number of Participants with hypokalaemia
Time frame: 28 days
Number of Participants with gastrointestinal bleeding
Time frame: 28 days
Number of Participants with acquired-weakness
Contact information is provided by the study sponsor or research team.
Alexandre BOURDIOL, PH
CONTACT
Karim ASHENOUNE, MD, PhD
CONTACT
Nantes University Hospital
Other
Acronym: DEXA-BURN
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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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