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Protocol and statistical analysis plan for the mega randomised registry trial comparing conservative vs. liberal oxygenation targets in adults with nonhypoxic ischaemic acute brain injuries and conditions in the intensive care unit (Mega-ROX Brains)

Young PJ 1 , Al-Fares A 2 , Aryal D 3 , Arabi YM 4 , Ashraf MS 5 , Bagshaw SM 6 Show all authors , Mat-Nor MB 7 , Beane A 8 , Borghi G 9 , de Oliveira Manoel AL 10 , Dullawe L 11 , Fazla F 11 , Fujii T 12 , Haniffa R 7 , Hodgson CL 12 , Hunt A 13 , Lawrence C 13 , Mackle D 13 , Mangal K 14 , Nichol AD 12 , Olatunji S 13 , Rashan A 8 , Rashan S 8 , Tomazini B 15 , Kasza J 16 , Mega-ROX management committee , Australian and New Zealand Intensive Care Society Clinical Trials Group , Brazilian Research in Intensive Care Network , Critical Care Asia and Africa Network , Irish Critical Care-Clinical Trials Group

Affiliations 

  • 1 Intensive Care Unit, Wellington Hospital, Wellington, New Zealand
  • 2 Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait
  • 3 Nepal Intensive Care Research Foundation, Kathmandu, Nepal
  • 4 College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, And Intensive Care Department, King Abdulaziz Medical City, Ministry of National-Guard Health Affairs, Riyadh, Saudi Arabia
  • 5 Department of Anesthesia and Critical Care Unit, Lady Reading Hospital, Peshawar, Pakistan
  • 6 Department of Critical Care Medicine, University of Alberta, And the Critical Care Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada
  • 7 Department of Anaesthesiology and Intensive Care, School of Medicine, International Islamic University of Malaysia, Kuantan, Pahang, Malaysia
  • 8 Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK
  • 9 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
  • 10 Department of Critical Care Medicine, Sultan Qaboos Comprehensive Cancer Care and Research Center, Muscat, Oman
  • 11 National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka
  • 12 Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia
  • 13 Medical Research Institute of New Zealand, Wellington, New Zealand
  • 14 Department of Critical Care Medicine, Fortis Escorts Hospital, Jaipur, India
  • 15 HCor Research Institute, São Paulo, Brazil
  • 16 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Crit Care Resusc, 2023 Mar;25(1):53-59.
PMID: 37876994 DOI: 10.1016/j.ccrj.2023.04.011

Abstract

BACKGROUND: The effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults who have nonhypoxic ischaemic encephalopathy acute brain injuries and conditions and are receiving invasive mechanical ventilation in the intensive care unit (ICU) is uncertain.

OBJECTIVE: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial.

DESIGN SETTING AND PARTICIPANTS: Mega-ROX Brains is an international randomised clinical trial, which 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 between 7500 and 9500 participants with nonhypoxic ischaemic encephalopathy acute brain injuries and conditions who are receiving unplanned invasive mechanical ventilation in the ICU.

MAIN OUTCOME MEASURES: The primary outcome is in-hospital all-cause mortality up to 90 d 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 Brains will compare the effect of conservative vs. liberal oxygen therapy regimens on 90-day in-hospital mortality in adults in the ICU with acute brain injuries and conditions. The protocol and planned analyses are reported here to mitigate analysis bias.

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

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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