• Bala Venkatesh, John Myburgh, Simon Finfer, Steve A R Webb, Jeremy Cohen, Rinaldo Bellomo, Colin McArthur, Christopher J Joyce, Dorrilyn Rajbhandari, Parisa Glass, Meg Harward, and ANZICS CTG investigators.
• Princess Alexandra Hospital and Wesley Hospital, University of Queensland, Brisbane, QLD, Australia. Bala_venkatesh@health.qld.gov.au
• Crit Care Resusc. 2013 Jun 1;15(2):83-8.

BackgroundThere is considerable global uncertainty on the role of low-dose corticosteroids in septic shock, which translates into variations in prescribing practices.ObjectiveTo describe the protocol for a large-scale multicentre randomised controlled trial in critically ill patients with septic shock, comparing the effects of hydrocortisone and placebo (in addition to standard treatment) on 90-day mortality and other outcomes such as shock reversal, duration of mechanical ventilation and quality of life.MethodsWe will recruit 3800 critically ill patients with septic shock treated in an intensive care unit, to concealed, randomised, parallel assignment of hydrocortisone or placebo. The primary outcome will be all-cause mortality at 90 days postrandomisation. Secondary outcomes will include ICU and hospital mortality, length of ICU stay and quality of life at 6 months. Subgroup analyses will be conducted in two predefined subgroups. All analyses will be conducted on an intention-to-treat basis.Results And ConclusionsThe run-in phase has been completed and the main trial commenced in February 2013. The trial should generate results that will inform and influence prescribing of corticosteroids in septic shock.

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