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).

Autor:	Young PJ; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.; Medical Research Institute of New Zealand, Wellington, New Zealand.; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia., Al-Fares A; Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait.; Kuwait Extracorporeal Life Support Program, Al-Amiri Center for Respiratory and Cardiac Failure, Ministry of Health, Kuwait., Aryal D; Nepal Intensive Care Research Foundation, Kathmandu, Nepal., Arabi YM; 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., Ashraf MS; Department of Anesthesia and Critical Care Unit, Lady Reading Hospital, Peshawar, Pakistan., Bagshaw SM; 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., Beane A; Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka., de Oliveira Manoel AL; Department of Critical Care Medicine, Sultan Qaboos Comprehensive Cancer Care and Research Center, Muscat, Oman., Dullawe L; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka., Fazla F; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka., Fujii T; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.; Intensive Care Unit, Jikei University Hospital, Tokyo, Japan.; Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan., Haniffa R; Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.; Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.; University College Hospital, London, United Kingdom., Hasan MS; Department of Anaesthesiology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia., Hodgson CL; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.; The Intensive Care Unit, Alfred Health, Melbourne, Victoria, Australia.; The George Institute for Global Health, Sydney, New South Wales, Australia., Hunt A; Medical Research Institute of New Zealand, Wellington, New Zealand., Lawrence C; Medical Research Institute of New Zealand, Wellington, New Zealand., Maia IS; HCor Research Institute, São Paulo, Brazil.; Brazilian Research in Intensive Care Network - BricNet, Brazil., Mackle D; Medical Research Institute of New Zealand, Wellington, New Zealand., Monti G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy., Nichol AD; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.; The George Institute for Global Health, Sydney, New South Wales, Australia.; School of Medicine and Medical Sciences, University College Dublin, Ireland.; Department of Anaesthesia and Intensive Care, St Vincent's Hospital, Dublin, Ireland., Olatunji S; Medical Research Institute of New Zealand, Wellington, New Zealand., Patodia S; Department of Critical Care Medicine, Apollo Hospitals, Chennai, India., Rashan A; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.; University College London, Institute of Health Informatics, London, United Kingdom., Rashan S; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.; Division of Surgery and Interventional Science, University College London, London, United Kingdom., Kasza J; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Jazyk:	angličtina
Zdroj:	Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine [Crit Care Resusc] 2024 Jun 21; Vol. 26 (2), pp. 87-94. Date of Electronic Publication: 2024 Jun 21 (Print Publication: 2024).
DOI:	10.1016/j.ccrj.2024.03.004
Abstrakt:	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). (© 2024 College of Intensive Care Medicine of Australia and New Zealand. Published by Elsevier B.V.)
Databáze:	MEDLINE
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