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.

IF 2.1 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2026-06-24 DOI:10.1186/s13063-026-09869-z

Alexandre Bourdiol, Nicolas Bruder, François Dépret, Delphine Flattres, Laurent Flet, June Fortin, Anne-Emmanuelle Gaufichon, Boris Glavnik, Matthieu Jeanne, Alexandra Jobert, Boris Jung, Anne-Claire Lukaszewicz, Noéline Mathelier, Morgane Péré, Xavier Pichon, Hugues Ravaux, Pierre-Joachim Mahé, Karim Asehnoune

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引用次数: 0

Abstract

Background: Severe 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.

Objectives: The 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.

Methods: DEXA-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 registration: EudraCT: 2024-517708-12-00; ClinicalTrials.gov: NCT06968559. Registered on April 22, 2025.

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早期地塞米松对严重烧伤（DEXA-BURN）主要并发症和全因死亡率的影响：一项多中心、随机、安慰剂对照、双盲试验的研究方案

背景：严重烧伤可导致强烈和持久的全身炎症，器官衰竭和主要并发症如急性呼吸窘迫综合征（ARDS）、急性肾损伤（AKI）和死亡率高。尽管皮质类固醇在各种重症监护环境中显示出益处，但尚未有足够有力的随机对照试验评估其在烧伤患者中的效果。目的：DEXA-BURN试验旨在评估早期给药地塞米松是否能降低严重烧伤成人主要并发症（中度至重度ARDS或2-3期AKI）的发生率和全因死亡率。方法：DEXA-BURN是一项多中心、随机、安慰剂对照、双盲试验，在法国10个重症监护病房进行。烧伤总体表面积(TBSA)≥20%的成年患者，在受伤后24小时内入院，需要机械通气，将随机（1:1）接受地塞米松（0.2 mg/kg/d IV，持续5天）或安慰剂。预先指定了两个终点，并使用分层测试策略进行了评估：(1)28天内的主要并发症（中重度ARDS或AKI KDIGO期≥2）；如果有统计学意义，(2)第90天的全因死亡率。次要终点包括院内感染、无呼吸机天数、重症监护病房/住院时间、CRP轨迹和类固醇相关不良事件。共有478名患者将被纳入研究。分析将遵循意向治疗和修改意向治疗原则。讨论：本试验将为皮质类固醇治疗在严重烧伤患者急性治疗中的有效性和安全性提供高质量的证据。研究结果可能为未来的指南提供信息，并改善这一研究不足的高死亡率人群的重症监护实践。试验注册：draft: 2024-517708-12-00；ClinicalTrials.gov: NCT06968559。于2025年4月22日注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.