ANZICS CTG Endorsed Study
The mega randomised registry trial comparing conservative vs. liberal oxygenation targets
Study Description
Background
Provision of life support (mechanical ventilation) is required for most critically ill patients who are admitted to an intensive care unit (ICU). Delivery of supplemental oxygen to ICU patients who require mechanical ventilation often exposes them to a high fraction of inspired oxygen (FIO2) and higher than normal arterial oxygen partial pressure (PaO2).
The ICU-ROX trial findings did not exclude clinically important effects of the oxygen regimens tested on mortality.
This 40,000 participant trial will be conducted in multiple countries and includes innovative trial design features:
Design
Mega-ROX is a series of multicentre, multinational, randomised, parallel-group, registry-embedded clinical trials nested within an overall 40,000-patient trial sample.
Hypothesis
That a conservative approach to oxygen therapy will reduce mortality compared to a liberal approach. However, we anticipate heterogeneity of treatment response and hypothesise that in patients with acute brain pathologies (other than hypoxic brain injuries) and patients with sepsis that liberal oxygen will reduce mortality compared with conservative oxygen.
Reference
CTG1920-01
Contact
Paul Young (Paul.Young@ccdhb.org.nz)