• Paul J Young, Abdulrahman Al-Fares, Diptesh Aryal, Yaseen M Arabi, Muhammad Sheharyar Ashraf, Sean M Bagshaw, Abigail Beane, Airton L de Oliveira Manoel, Layoni Dullawe, Fathima Fazla, Tomoko Fujii, Rashan Haniffa, Carol L Hodgson, Anna Hunt, Bharath Kumar Tirupakuzhi Vijayaraghavan, Giovanni Landoni, Cassie Lawrence, Israel Silva Maia, Diane Mackle, Mohd Zulfakar Mazlan, Alistair D Nichol, Shaanti Olatunji, Aasiyah Rashan, Sumayyah Rashan, Jessica Kasza, Mega-ROX management committee, Australian and New Zealand Intensive Care Society Clinical Trials Group, Critical Care Asia and Africa Network, and Irish Critical Care-Clinical Trials Group.
• Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
• Crit Care Resusc. 2023 Jun 1; 25 (2): 106112106-112.

BackgroundThe 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.ObjectiveThe objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Sepsis trial.Design Setting And ParticipantsThe 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 MeasuresThe 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 ConclusionsMega-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.© 2023 The Authors.

6 keywords...

hide…