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)

• Published in: Critical care and resuscitation Vol. 26; no. 2; pp. 87 - 94
• Main Authors: Young, Paul J., Al-Fares, Abdulrahman, Aryal, Diptesh, Arabi, Yaseen M., Ashraf, Muhammad Sheharyar, Bagshaw, Sean M., Beane, Abigail, de Oliveira Manoel, Airton L., Dullawe, Layoni, Fazla, Fathima, Fujii, Tomoko, Haniffa, Rashan, Hasan, Mohd Shahnaz, Hodgson, Carol L., Hunt, Anna, Lawrence, Cassie, Maia, Israel Silva, Mackle, Diane, Monti, Giacomo, Nichol, Alistair D., Olatunji, Shaanti, Patodia, Sristi, Rashan, Aasiyah, Rashan, Sumayyah, Kasza, Jessica
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.06.2024; Elsevier
• Subjects: Cardiac arrest; Original; Oxygen; Protocol; Randomised clinical trial; Oxygen; Protocol; Randomised clinical trial; Cardiac arrest
• ISSN: 1441-2772; 2652-9335
• DOI: 10.1016/j.ccrj.2024.03.004

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. To summarise the protocol and statistical analysis plan for the Mega-ROX HIE trial. 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. 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. 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. Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).