학술논문
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).
Document Type
Academic Journal
Author
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, University of Alberta, and 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.; 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.; Tirupakuzhi Vijayaraghavan BK; Department of Critical Care Medicine, Apollo Hospitals, Chennai, India.; The George Institute for Global Health, New Delhi, India.; Landoni G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.; Lawrence C; Medical Research Institute of New Zealand, Wellington, New Zealand.; Maia IS; HCor Research Institute, São Paulo, Brazil.; Mackle D; Medical Research Institute of New Zealand, Wellington, New Zealand.; Mazlan MZ; Department of Anaesthesiology and Intensive Care, School of Medical Sciences, Universiti Sains Malaysia, Kelantan, Malaysia.; Department of Anaesthesiology and Intensive Care, Hospital Universiti Sains Malaysia, Kelantan, Malaysia.; Nichol AD; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.; The Intensive Care Unit, Alfred Health, Melbourne, Victoria, 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.; 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.
Source
Publisher: Elsevier B.V. on behalf of College of Intensive Care Medicine of Australia and New Zealand Country of Publication: Netherlands NLM ID: 100888170 Publication Model: eCollection Cited Medium: Print ISSN: 1441-2772 (Print) Linking ISSN: 14412772 NLM ISO Abbreviation: Crit Care Resusc Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
1441-2772
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.
(© 2023 The Authors.)
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.
(© 2023 The Authors.)