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.
OBJECTIVE: The objective of this study was to summarise the protocol and statistical analysis plan for the Mega-ROX Brains trial.
DESIGN SETTING AND PARTICIPANTS: Mega-ROX Brains is an international randomised clinical trial, which 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 between 7500 and 9500 participants with nonhypoxic ischaemic encephalopathy acute brain injuries and conditions who are receiving unplanned invasive mechanical ventilation in the ICU.
MAIN OUTCOME MEASURES: The primary outcome is in-hospital all-cause mortality up to 90 d 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 Brains will compare the effect of conservative vs. liberal oxygen therapy regimens on 90-day in-hospital mortality in adults in the ICU with acute brain injuries and conditions. The protocol and planned analyses are reported here to mitigate analysis bias.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN 12620000391976).
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).
DESIGN: An online survey was conducted.
SETTING AND PARTICIPANTS: An online survey was distributed to intensive care doctors in sites participating in a large-scale international randomised clinical trial evaluating oxygen therapy targets in 15 countries and to additional intensive care clinicians from Canada.
MAIN OUTCOME MEASURES: Outcomes included the expressed level of support for a large pragmatic trial to evaluate minimum MAP targets in critically ill adults and stated current practice and acceptability of minimum MAP for specific scenarios.
RESULTS: The response rate to our survey for respondents who work in sites participating in the mega randomised registry trial research program was 265 out of 701 (37.8%), with an additional 56 out of 256 (21.8%) responses obtained from a direct email containing a link to the survey sent to intensive care clinicians in Canada. A total of 309 of 321 respondents (96.3%) were supportive, in principle, of conducting a very large pragmatic trial to evaluate MAP targets in intensive care unit patients receiving noradrenaline. The commonest response in all scenarios was to agree that the optimal minimum MAP target was uncertain. In all scenarios, except for active bleeding, the most common reported minimum MAP target was 65 mmHg; for patients who were actively bleeding, the most common reported target was 60 mmHg.
CONCLUSIONS: Our data suggest that intensive care clinicians are broadly supportive of a large-scale pragmatic minimum MAP targets in intensive care unit patients receiving noradrenaline.