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Protocol and statistical analysis plan for the mega randomised registry trial comparing conservative vs. liberal oxygenation targets in adults with sepsis in the intensive care unit (Mega-ROX Sepsis)

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 , Hodgson CL 10 , Hunt A 11 , Tirupakuzhi Vijayaraghavan BK 12 , Landoni G 13 , Lawrence C 11 , Maia IS 14 , Mackle D 11 , Mazlan MZ 15 , Nichol AD 10 , Olatunji S 11 , Rashan A 9 , Rashan S 9 , Kasza J 16 , Mega-ROX management committee , Australian and New Zealand Intensive Care Society Clinical Trials Group , 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 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 Medical Research Institute of New Zealand, Wellington, New Zealand
  • 12 Department of Critical Care Medicine, Apollo Hospitals, Chennai, India
  • 13 Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
  • 14 HCor Research Institute, São Paulo, Brazil
  • 15 Department of Anaesthesiology and Intensive Care, School of Medical Sciences, Universiti Sains Malaysia, Kelantan, Malaysia
  • 16 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Crit Care Resusc, 2023 Jun;25(2):106-112.
PMID: 37876605 DOI: 10.1016/j.ccrj.2023.04.008

Abstract

BACKGROUND: The effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with sepsis receiving unplanned 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 Sepsis trial.

DESIGN SETTING AND PARTICIPANTS: The Mega-ROX Sepsis trial is an international randomised clinical trial that will be conducted within an overarching 40,000-patient registry-embedded clinical trial comparing conservative and liberal ICU oxygen therapy regimens. We anticipate that between 10,000 and 13,000 patients with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU will be enrolled in this trial.

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 patients discharged home.

RESULTS AND CONCLUSIONS: Mega-ROX Sepsis will compare the effect of conservative vs. liberal oxygen therapy on 90-day in-hospital mortality in adults with sepsis who are receiving unplanned invasive mechanical ventilation in the ICU. The protocol and a prespecified approach to analyses are reported here to mitigate analysis bias.

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

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