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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, 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; Hodgson, Carol L; Hunt, Anna; Tirupakuzhi Vijayaraghavan, Bharath Kumar; Landoni, Giovanni; Lawrence, Cassie; Maia, Israel Silva; Mackle, Diane; Mazlan, Mohd Zulfakar; Nichol, Alistair D; Olatunji, Shaanti; Rashan, Aasiyah; Rashan, Sumayyah; Kasza, Jessica.
Afiliación
  • Young PJ; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
  • Al-Fares A; Medical Research Institute of New Zealand, Wellington, New Zealand.
  • Aryal D; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
  • Arabi YM; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
  • Ashraf MS; Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait.
  • Bagshaw SM; Kuwait Extracorporeal Life Support Program, Al-Amiri Center for Respiratory and Cardiac Failure, Ministry of Health, Kuwait.
  • Beane A; Nepal Intensive Care Research Foundation, Kathmandu, Nepal.
  • de Oliveira Manoel AL; 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.
  • Dullawe L; Department of Anesthesia and Critical Care Unit, Lady Reading Hospital, Peshawar, Pakistan.
  • Fazla F; Department of Critical Care Medicine, University of Alberta, and Alberta Health Services, Edmonton, Alberta, Canada.
  • Fujii T; Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.
  • Haniffa R; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.
  • Hodgson CL; Department of Critical Care Medicine, Sultan Qaboos Comprehensive Cancer Care and Research Center, Muscat, Oman.
  • Hunt A; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.
  • Tirupakuzhi Vijayaraghavan BK; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.
  • Landoni G; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
  • Lawrence C; Intensive Care Unit, Jikei University Hospital, Tokyo, Japan.
  • Maia IS; Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.
  • Mackle D; Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom.
  • Mazlan MZ; National Intensive Care Surveillance - MORU (NICS-MORU), Colombo, Sri Lanka.
  • Nichol AD; Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
  • Olatunji S; University College Hospital, London, United Kingdom.
  • Rashan A; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia.
  • Rashan S; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia.
  • Kasza J; The Intensive Care Unit, Alfred Health, Melbourne, Victoria, Australia.
Crit Care Resusc ; 25(2): 106-112, 2023 Jun.
Article en En | MEDLINE | ID: mdl-37876605
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Crit Care Resusc Asunto de la revista: TERAPIA INTENSIVA Año: 2023 Tipo del documento: Article País de afiliación: Nueva Zelanda Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Crit Care Resusc Asunto de la revista: TERAPIA INTENSIVA Año: 2023 Tipo del documento: Article País de afiliación: Nueva Zelanda Pais de publicación: Países Bajos