氟化可的松治疗动脉瘤性蛛网膜下腔出血患者：一项国际3期、随机、安慰剂对照、多中心试验方案

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2025-06-01 DOI:10.1016/j.ccrj.2025.100116

Jeremy Cohen FCICM, PhD , Anthony Delaney FCICM, FACEM, PhD , Andrew Udy FCICM, PhD , Christopher Andersen FCICM, PhD , Craig S. Anderson PhD , Judith Bellapart FCICM, PhD , Louise M. Burrell MBChB, MD , Anthony Devaux PhD , David M. Evans PhD , Emily Fitzgerald RN, MN , Tessa Garside FCICM, PhD , Naomi Hammond RN, PhD , Miranda Hardie BN, GradCertCritCare , Rosalind L. Jeffree M.Sc, FRACS , Serena Knowles RN, PhD , Melissa Lassig-Smith RN , Qiang Li AStat MBiostat , Gladness Nethathe FCA (SA), Cert Crit Care (SA) , Dorrilyn Rajbhandari PGDip Clin Nurs , Mahesh Ramanan FCICM, PhD , Balasubramanian Venkatesh FCICM, MD

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引用次数: 0

摘要

背景和原因低钠血症是动脉瘤性蛛网膜下腔出血（aSAH）后常见的并发症，且与较差的预后相关。氟化可的松是一种合成的矿物皮质激素，可能是治疗低钠血症的有效方法，但其对临床结果的影响尚不清楚。目的本研究的目的是描述氟化可的松在动脉瘤性蛛网膜下腔出血（FLASH）试验中的研究方案。FLASH试验是一项三期随机、盲法、安慰剂对照、多中心试验，比较了澳大利亚、新西兰和英国医院的成年急性aSAH患者接受14天氟化可的松治疗和匹配安慰剂治疗。计划样本量为524例。主要结局指标：主要结局指标为随机化后6个月的修正兰金量表评分。次要终点是在同一时间点评估的蛛网膜下腔出血结局工具评分。第三阶段结果以核心结果集的国际准则为基础，并包括经济和生活质量分析。预先指定的亚组分析将包括aSAH严重程度和随机低钠血症的存在。结果和结论：FLASH试验计划于2025年5月开始招募。registrationNCT06409364审判。

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Fludrocortisone to treat patients with aneurysmal subarachnoid haemorrhage: Protocol for an international, phase 3, randomised, placebo-controlled, multicentre trial

Background and rationale

Hyponatraemia is a common complication after aneurysmal subarachnoid haemorrhage (aSAH) and is associated with worse outcomes. Fludrocortisone, a synthetic mineralocorticoid, may be an effective treatment for hyponatraemia, but its effect on clinical outcomes is unknown.

Objectives

The objective of this study was to describe the study protocol for the Fludrocortisone in Aneurysmal Subarachnoid Haemorrhage (FLASH) trial.

Design setting and participants

The FLASH trial is a phase three randomised, blinded, placebo-controlled, multicentre trial comparing 14 days of treatment with fludrocortisone to matching placebo in adult patients with acute aSAH at hospitals in Australia, New Zealand, and the United Kingdom. The planned sample size is 524 patients.

Main outcome measures

The primary outcome measure is the Modified Rankin Scale score assessed at 6 months after randomisation. The secondary outcome is the Subarachnoid Haemorrhage Outcome Tool score assessed at the same time point. Tertiary outcomes are based on international guidelines for core outcome sets and include economic and quality-of-life analyses. Prespecified subgroups for analysis will comprise aSAH severity and the presence of hyponatraemia at randomisation.

Results and conclusions

The FLASH trial aims to commence recruitment in May 2025.

Trial registration

NCT06409364.

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.