Evidence map›Paper›PMID 42337788›Full record

ArticleTrials2026

Effect of early dexamethasone on major complications and all-cause mortality in severe burns (DEXA-BURN): study protocol for a multicenter, randomized, placebo-controlled, double-blind trial.

Alexandre Bourdiol, Nicolas Bruder, François Dépret, Delphine Flattres, Laurent Flet, June Fortin, Anne-Emmanuelle Gaufichon, Boris Glavnik, Matthieu Jeanne, Alexandra Jobert and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06968559 (Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06968559 phase3recruitingnot on this map

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

TypeinterventionalSponsorNantes University HospitalRan2025 to 2029Enrolled478ConditionsSevere BurnsArmsDexamethasone, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Alexandre BourdiolImmunologie Et Infectiologie, Nantes Université, CHU de Nantes, Service d'Anesthésie Réanimation Chirurgicale, INSERM CIC, 0004, Nantes, France. alexandre.bourdiol@chu-nantes.fr.ORCID http://orcid.org/0009-0007-9946-8453
Nicolas BruderDeparment of Anesthesiology and Critical Care Medicine, La Conception Hospital, APHM, Marseille, France.
François DépretDeparment of Anesthesiology and Surgical Critical Care and Burn Unit, Saint-Louis Hospital, AP-HP, Paris, Université de Paris, Paris, France.
Delphine FlattresImmunologie Et Infectiologie, Nantes Université, CHU de Nantes, Service d'Anesthésie Réanimation Chirurgicale, INSERM CIC, 0004, Nantes, France.
Laurent FletNantes Université, CHU de Nantes, Pharmacie Hospitalière de Nantes, Nantes, France.
June FortinDirection de La Recherche Et de L'Innovation, CHU de Nantes, Nantes, France.
Anne-Emmanuelle GaufichonDeparment of Anesthesiology and Critical Care Medicine, CHU de Bordeaux, Bordeaux, France.
Boris GlavnikDeparment of Anesthesiology and Critical Care Medicine, CHR Metz, Metz, France.
Matthieu JeanneULR 7365 - GRITA - Groupe de Recherche Sur Les Formes Injectables Et Les Technologies Associees, University of Lille, Lille, France.
Alexandra JobertCHU de Nantes, Nantes, France.
Boris JungService de Médecine-Intensive Réanimation, CHU de Montpellier, Montpellier, France.
Anne-Claire LukaszewiczDeparment of Anesthesiology and Critical Care Medicine, HCL, Lyon, France.
Noéline MathelierImmunologie Et Infectiologie, Nantes Université, CHU de Nantes, Service d'Anesthésie Réanimation Chirurgicale, INSERM CIC, 0004, Nantes, France.
Morgane PéréDirection de la Recherche, Plateforme de Méthodologie et de Biostatistiques, CHU de Nantes, Nantes, France.
Xavier PichonDeparment of Anesthesiology and Critical Care Medicine, CHU de Toulouse, Toulouse, France.
Hugues RavauxDeparment of Anesthesiology and Critical Care Medicine, CHU de Tours, Tours, France.
Pierre-Joachim MahéImmunologie Et Infectiologie, Nantes Université, CHU de Nantes, Service d'Anesthésie Réanimation Chirurgicale, INSERM CIC, 0004, Nantes, France.
Karim AsehnouneImmunologie Et Infectiologie, Nantes Université, CHU de Nantes, Service d'Anesthésie Réanimation Chirurgicale, INSERM CIC, 0004, Nantes, France.
DEXA-BURN study group

Funding

Ministère de la Santé et des Services sociaux PHRC-Call 2023
6 · The paper itself

Abstract

backgroundSevere burns lead to intense and prolonged systemic inflammation and high rates of organ failure and major complications such as acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) and mortality. Although corticosteroids have shown benefits in various critical care settings, no adequately powered randomized controlled trial has yet evaluated their effect in burn patients.

objectivesThe DEXA-BURN trial aims to assess whether early administration of dexamethasone reduces the incidence of major complications (moderate-to-severe ARDS or stage 2-3 AKI) and all-cause mortality in adults with severe burns.

methodsDEXA-BURN is a multicenter, randomized, placebo-controlled, double-blind trial conducted in 10 French intensive care units. Adult patients with ≥ 20% total body surface area (TBSA) burns, admitted within 24 h of injury and requiring mechanical ventilation, will be randomized (1:1) to receive either dexamethasone (0.2 mg/kg/day IV for 5 days) or placebo. Two endpoints are pre-specified and evaluated using a hierarchical testing strategy: (1) major complications within 28 days (moderate-to-severe ARDS or AKI KDIGO stages ≥ 2); and, if statistically significant, (2) all-cause mortality at day 90. Secondary endpoints include nosocomial infections, ventilator-free days, intensive care unit /hospital stay, CRP trajectory, and steroid-related adverse events. A total of 478 patients will be enrolled. Analyses will follow the intention-to-treat and modified intention-to-treat principle. DISCUSSION: This trial will provide high-quality evidence on the effectiveness and safety of corticosteroid therapy in the acute management of severely burned patients. Findings may inform future guidelines and improve critical care practices for this understudied population with a high risk of mortality.

trial registrationEudraCT: 2024-517708-12-00; ClinicalTrials.gov: NCT06968559. Registered on April 22, 2025.

Indexed as

Acute Kidney InjuryAnti-Inflammatory AgentsBurnsDexamethasoneGlucocorticoidsRespiratory Distress SyndromeAdultDouble-Blind MethodFranceHumansIntensive Care UnitsMulticenter Studies as TopicRandomized Controlled Trials as TopicRespiration, ArtificialTime FactorsTreatment OutcomeAnti-Inflammatory AgentsDexamethasoneGlucocorticoidsDexamethasoneIntensive care unitSevere burns

Identifiers

PMID42337788
PMCPMC13548467

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.