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)
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).
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.