Protocol and statistical analysis plan for the mega randomised registry trial comparing conservative vs. liberal oxygenation targets in adults in the intensive care unit with suspected hypoxic ischaemic encephalopathy following a cardiac arrest (Mega-ROX HIE)

IF 1.4 4区 医学 Q3 CRITICAL CARE MEDICINE Critical Care and Resuscitation Pub Date : 2024-06-01 DOI:10.1016/j.ccrj.2024.03.004
Paul J. Young MBChB, FCICM, PhD , Abdulrahman Al-Fares MBChB, FRCPC, ABIM, MRCP , Diptesh Aryal MD , Yaseen M. Arabi MD , Muhammad Sheharyar Ashraf MD , Sean M. Bagshaw MD, MSc, PhD , Abigail Beane PhD , Airton L. de Oliveira Manoel MD PhD , Layoni Dullawe BSc , Fathima Fazla BSc , Tomoko Fujii MD, PhD , Rashan Haniffa PhD , Mohd Shahnaz Hasan MBBS, MAnes , Carol L. Hodgson PT, MPhil, PhD , Anna Hunt BN , Cassie Lawrence BN , Israel Silva Maia , Diane Mackle MN, PhD , Giacomo Monti MD , Alistair D. Nichol PhD , Jessica Kasza PhD
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Abstract

Background

The effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with hypoxic ischaemic encephalopathy (HIE) following a cardiac arrest who are receiving invasive mechanical ventilation in the intensive care unit (ICU) is uncertain.

Objective

To summarise the protocol and statistical analysis plan for the Mega-ROX HIE trial.

Design, setting and participants

Mega-ROX HIE is an international randomised clinical trial that will be conducted within an overarching 40,000-participant registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We expect to enrol approximately 4000 participants with suspected HIE following a cardiac arrest who are receiving invasive mechanical ventilation in the ICU.

Main outcome measures

The primary outcome is in-hospital all-cause mortality up to 90 days from the date of randomisation. Secondary outcomes include duration of survival, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and the proportion of participants discharged home.

Results and conclusions

Mega-ROX HIE will compare the effect of conservative vs. liberal oxygen therapy regimens on day-90 in-hospital mortality in adults in the ICU with suspected HIE following a cardiac arrest. The protocol and planned analyses are reported here to mitigate analysis bias.

Trial registration

Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).

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在重症监护病房对心脏骤停后疑似缺氧缺血性脑病的成人进行保守与宽松氧合目标比较的大型随机登记试验(Mega-ROX HIE)的方案和统计分析计划
背景在重症监护病房(ICU)接受有创机械通气的缺氧缺血性脑病(HIE)成人患者中,保守氧疗与宽松氧疗对 90 天院内死亡率的影响尚不确定。设计、环境和参与者Mega-ROX HIE是一项国际随机临床试验,将在一项有40,000名参与者的总体登记嵌入式临床试验中进行,比较保守和宽松的ICU氧疗方案。我们预计将招募约 4000 名心脏骤停后疑似发生 HIE 并在重症监护室接受有创机械通气的参与者。主要结果测量主要结果是自随机化之日起 90 天内的院内全因死亡率。次要结果包括存活时间、机械通气时间、重症监护室住院时间、住院时间和出院回家的参与者比例。结果和结论Mega-ROX HIE将比较保守与宽松氧疗方案对重症监护室中心脏骤停后疑似HIE的成人90天院内死亡率的影响。在此报告方案和计划分析,以减少分析偏差。试验注册澳大利亚和新西兰临床试验注册中心(ACTRN 12620000391976)。
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来源期刊
Critical Care and Resuscitation
Critical Care and Resuscitation CRITICAL CARE MEDICINE-
CiteScore
7.70
自引率
3.40%
发文量
44
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.
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