TY - JOUR
T1 - 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)
AU - Young, Paul J.
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 - Hasan, Mohd Shahnaz
AU - Hodgson, Carol L.
AU - Hunt, Anna
AU - Lawrence, Cassie
AU - Maia, Israel Silva
AU - Mackle, Diane
AU - Monti, Giacomo
AU - Nichol, Alistair D.
AU - Olatunji, Shaanti
AU - Patodia, Sristi
AU - Rashan, Aasiyah
AU - Rashan, Sumayyah
AU - Kasza, Jessica
AU - for the Mega-ROX management committee, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Brazilian Research in Intensive Care Network, the Critical Care Asia and Africa Network, the Irish Critical Care-Clinical Trials Group
N1 - Funding Information:
Mega-ROX HIE is funded by grants from the Health Research Council of New Zealand and by an unrestricted donation from the Alpha Charitable Trust. In Canada, Mega-ROX has received funding from the Pragmatic Trials Platform \u2013 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 Brazil by HCor Research Institute. 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 (part of the National Intensive Care Surveillance, Mahidol\u2013Oxford 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. This study is approved by the Japanese Intensive Care Research Group.
Publisher Copyright:
© 2024 Elsevier B.V.
PY - 2024/6
Y1 - 2024/6
N2 - 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).
AB - 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).
KW - Cardiac arrest
KW - Oxygen
KW - Protocol
KW - Randomised clinical trial
UR - https://www.scopus.com/pages/publications/85196489839
U2 - 10.1016/j.ccrj.2024.03.004
DO - 10.1016/j.ccrj.2024.03.004
M3 - Article
C2 - 39072241
AN - SCOPUS:85196489839
SN - 1441-2772
VL - 26
SP - 87
EP - 94
JO - Critical Care and Resuscitation
JF - Critical Care and Resuscitation
IS - 2
ER -