TY - JOUR
T1 - 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)
AU - Al-Fares, Abdulrahman
AU - Aryal, Diptesh
AU - Arabi, Yaseen M.
AU - Ashraf, Muhammad Sheharyar
AU - Bagshaw, Sean M.
AU - Beane, Abigail
AU - de Oliveira Manoel, Airton L.
AU - Dullawe, Layoni
AU - Fazla, Fathima
AU - Fujii, Tomoko
AU - Haniffa, Rashan
AU - Hodgson, Carol L.
AU - Hunt, Anna
AU - Tirupakuzhi Vijayaraghavan, Bharath Kumar
AU - Landoni, Giovanni
AU - Lawrence, Cassie
AU - Maia, Israel Silva
AU - Mackle, Diane
AU - Mazlan, Mohd Zulfakar
AU - Nichol, Alistair D.
AU - Olatunji, Shaanti
AU - Rashan, Aasiyah
AU - Rashan, Sumayyah
AU - for the Mega-ROX management committee, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Critical Care Asia and Africa Network, the Irish Critical Care-Clinical Trials Group
A2 - Young, Paul J.
A2 - Kasza, Jessica
N1 - Funding Information:
Mega-ROX Sepsis is funded by grants from the Health Research Council of New Zealand (ref 20/084) and by an unrestricted donation from the Alpha Charitable Trust. In Canada, Mega-ROX has received funding from the Pragmatic Trials Platform – Alberta Strategy for Patient-Oriented Research (SPOR) Support Unit. The funding bodies have had no input into the design or conduct of the trial or into the statistical analysis plan and will have no input into analysis or reporting of the results. The study is coordinated in New Zealand by the Medical Research Institute of New Zealand and in Australia by the Australian and New Zealand Intensive Care Research Centre. The study is coordinated in Ireland by the Irish Critical Care Clinical Trials Network, which is supported by the Health Research Board. The study is coordinated in Canada by the University of Alberta. The study is coordinated in Japan by Jikei University. The study is coordinated in Asia by the Critical Care Asia Network and in Africa by the Critical Care Africa Network (parts of the National Intensive Care Surveillance, Mahidol–Oxford Tropical Medicine Research Unit [NICS-MORU] collaboration), which are supported by a Wellcome Innovations grant (215522). This study is endorsed by the Australia and New Zealand Intensive Care Society Clinical Trials Group, the Irish Critical Care Clinical Trials Group, and the Alberta Health Services Critical Care Strategic Clinical Network and approved by the Japanese Intensive Care Research Group.
Publisher Copyright:
© 2023 The Authors
PY - 2023/6
Y1 - 2023/6
N2 - 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.
AB - 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.
KW - Critical care
KW - Hyperoxaemia
KW - Hypoxaemia
KW - Intensive care
KW - Oxygen therapy
KW - Sepsis
UR - http://www.scopus.com/inward/record.url?scp=85165255534&partnerID=8YFLogxK
U2 - 10.1016/j.ccrj.2023.04.008
DO - 10.1016/j.ccrj.2023.04.008
M3 - Article
C2 - 37876605
AN - SCOPUS:85165255534
SN - 1441-2772
VL - 25
SP - 106
EP - 112
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 2
ER -