ANZICS CTG Endorsed Study

Mega-ROX

Mega-ROX: Multiple phase 3 multi-centre, randomised, registry-embedded, single blinded clinical trials comparing conservative oxygen therapy to liberal oxygen therapy in mechanically ventilated adults in the intensive care unit nested within a 40,000 patient mega trial.

Study Description

Mega-ROX is a series of multicentre, multinational, randomised, parallel-group, registry-embedded clinical trials nested within an overall 40,000-patient trial sample.

Our study hypothesis is 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.

Management Committee

Paul Young (Chair), Aida Malik Al Kindy, Abdulrahman Al-Fares, Yaseen Arabi, Diptesh Arayal, Muhammad Sheharyar Ashraf, Sean Bagshaw, Abi Beane, Rinaldo Bellomo, Kathy Brickell, Gilles Capellier, Alexandre Cavalcanti, Layone Dullawe, Simon Finfer, Tomoko Fujii, Rashan Haniffa, Mohd Shahnaz Hasan, Carol Hodgson, Jessica Kasza, Bharath Kumar, Giovanni Landoni, Ed Litton, Diane Mackle (Project Manager), Israel Maia, Airton Manoel, Anne Mather, Stacey Morgan (Research Coordinator), Mohd Zulfakar Bin Mazlan, Colin McArthur, Alistair Nichol, Niklas Nielsen, Dawn Opgenorth, David Pilcher, Matthew Semler, Ian Seppelt, Bruno Tomazini, Nor’azim Bin Mohd Yunos, Statisticians: Michael Bailey (unblinded), Jessica Kasza (blinded)

Administering Institution

Medical Research Institute of NZ

Sample Size

40,000

Funding

Philanthropic donation, Health Research Council NZ

Reference

CTG1920-01, ACTRN12620000391976

Contact

Diane Mackle  (email)