Fulltext

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)

Young PJ 1 , Al-Fares A 2 , Aryal D 3 , Arabi YM 4 , Ashraf MS 5 , Bagshaw SM 6 Show all authors , Beane A 7 , de Oliveira Manoel AL 8 , Dullawe L 9 , Fazla F 9 , Fujii T 10 , Haniffa R 7 , Hasan MS 11 , Hodgson CL 10 , Hunt A 12 , Lawrence C 12 , Maia IS 13 , Mackle D 12 , Monti G 14 , Nichol AD 10 , Olatunji S 12 , Patodia S 15 , Rashan A 9 , Rashan S 9 , 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, and , 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, Faculty of Medicine and Dentistry, University of Alberta, and the Critical Care Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada
  • 7 Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom
  • 8 Department of Critical Care Medicine, Sultan Qaboos Comprehensive Cancer Care and Research Center, Muscat, Oman
  • 9 National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka
  • 10 Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia
  • 11 Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia
  • 12 Medical Research Institute of New Zealand, Wellington, New Zealand
  • 13 HCor Research Institute, São Paulo, Brazil
  • 14 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
  • 15 Department of Critical Care Medicine, Apollo Hospitals, Chennai, India
  • 16 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Crit Care Resusc, 2024 Jun;26(2):87-94.
PMID: 39072241 DOI: 10.1016/j.ccrj.2024.03.004

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).

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

Similar publications