Dexamethasone Versus Placebo in Comatose Survivors of Out-of-Hospital Cardiac Arrest: Study Protocol for a Multicenter Randomized Comparison Within the Danish Out-of-Hospital Cardiac Arrest Trial (DANOHCA).

IF 1.9 4区医学 Q2 ANESTHESIOLOGY

Acta Anaesthesiologica Scandinavica Pub Date : 2026-08-01 DOI:10.1111/aas.70287

Jo B Andreasen, Anders Morten Grejs, Simon Mölström, Lars P K Andersen, Sören Möller, Steffen Christensen, Henrik Schmidt, Jacob E Møller, Martin A S Meyer, Jesper Kjærgaard, Alexander W Erbs, Bodil S Rasmussen, Christian Hassager

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引用次数: 0

Abstract

Background: The inflammatory response to whole-body ischemia, as seen in comatose survivors after out-of-hospital cardiac arrest (OHCA), is associated with increased morbidity and mortality. Early high-dose dexamethasone may dampen the inflammatory response, which may diminish secondary brain damage and other organ injury and decrease mortality. The aim is to evaluate the effect of high-dose dexamethasone in post-resuscitation care.

Methods: The Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial is an investigator-initiated, multicenter, randomized, controlled trial evaluating four post-resuscitation interventions in adult patients resuscitated after OHCA including blinded early administration of high-dose dexamethasone compared with placebo (isotonic saline). Adult OHCA patients with presumed cardiac etiology and sustained return of spontaneous circulation will be randomized 1:1 to receive 20 mg of dexamethasone or placebo immediately after inclusion in the trial and repeated the following two mornings for a total of three doses. The primary outcome is all-cause mortality within 90 days using a log-binomial regression analysis to estimate the relative risk of death from any cause between randomization and Day 90. Enrollment began in June 2023, with the aim to include 1000 patients at five sites in 3-4 years. The trial is registered at clinicaltrials.gov (identifier: NCT05895838) and euclinicaltrials.eu (2024-515997-28-00).

Perspectives: It is of paramount importance to optimize post-resuscitation care through large-scale randomized trials. Global ischemia-reperfusion-induced inflammatory response with resulting organ failures represents a possible target for interventions after OHCA. This part of the DANOHCA trial will provide new evidence on the impact of high-dose dexamethasone in survivors of OHCA.

Trial registration: Clinical Trials Information System (CTIS): 2024-515997-28-00.

查看原文本刊更多论文

地塞米松与安慰剂在院外心脏骤停昏迷幸存者中的作用：丹麦院外心脏骤停试验（DANOHCA）的多中心随机比较研究方案

背景：院外心脏骤停（OHCA）后昏迷幸存者对全身缺血的炎症反应与发病率和死亡率增加有关。早期大剂量地塞米松可抑制炎症反应，减少继发性脑损伤和其他器官损伤，降低死亡率。目的是评价大剂量地塞米松在复苏后护理中的作用。方法：丹麦院外心脏骤停（DANOHCA）试验是一项研究者发起的、多中心、随机、对照试验，评估四种复苏后干预措施对OHCA后复苏的成年患者的影响，包括盲法早期给药大剂量地塞米松与安慰剂（等渗盐水）的比较。假定心脏病因和持续自发循环恢复的成年OHCA患者在纳入试验后将按1:1随机分配，立即接受20mg地塞米松或安慰剂，并在接下来的两个早晨重复，共三次剂量。主要结局是90天内的全因死亡率，使用对数二项回归分析来估计随机分配和第90天之间任何原因的相对死亡风险。该项目于2023年6月开始招募，目标是在3-4年内在5个地点招募1000名患者。该试验已在clinicaltrials.gov（标识符：NCT05895838）和eucclinicaltrials注册。欧盟(2024-515997-28-00)。观点：通过大规模随机试验优化复苏后护理是至关重要的。全身缺血再灌注引起的炎症反应导致器官衰竭是OHCA后干预的可能目标。DANOHCA试验的这一部分将为大剂量地塞米松对OHCA幸存者的影响提供新的证据。试验注册：临床试验信息系统（CTIS）： 2024-515997-28-00。

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来源期刊

Acta Anaesthesiologica Scandinavica 医学-麻醉学

CiteScore

4.30

自引率

9.50%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Acta Anaesthesiologica Scandinavica publishes papers on original work in the fields of anaesthesiology, intensive care, pain, emergency medicine, and subjects related to their basic sciences, on condition that they are contributed exclusively to this Journal. Case reports and short communications may be considered for publication if of particular interest; also letters to the Editor, especially if related to already published material. The editorial board is free to discuss the publication of reviews on current topics, the choice of which, however, is the prerogative of the board. Every effort will be made by the Editors and selected experts to expedite a critical review of manuscripts in order to ensure rapid publication of papers of a high scientific standard.