Adjunctive corticosteroid treatment in critically ill patients with septic shock (ADRENAL)

Septic shock is hypotension or tissue hypoperfusion due to infection. It is a major cause of mortality worldwide. The accepted principles of therapy for septic shock include prompt resuscitation and administration of antibiotics, source control, intravenous fluid therapy and organ system support with vasopressor drugs, mechanical ventilation, and renal replacement therapy as required.

Treatment with corticosteroids has long been advocated as a possible means to modulate the inflammatory process. Despite many trials, there is no consensus as to the effectiveness of corticosteroid therapy and their use in clinical practice varies among clinicians. Corticosteroids are cheap and a trial providing unequivocal evidence of effectiveness would result in immediate modification of clinical practice in Australia, as well as in both developed and developing countries around the world.

Aims

The primary aim of the ADRENAL study is to determine if hydrocortisone, compared to placebo, reduces 90-day all-cause mortality in patients admitted to an ICU with septic shock.

Design

The ADRENAL study is a multi-centre, randomised, blinded, placebo controlled trial comparing intravenous hydrocortisone with placebo in critically ill patients with septic shock in Intensive Care.

Methods

In this study, 3800 patients will be enrolled at approximately 70 Intensive Care Units. Eligible patients will be randomised to receive either intravenous hydrocortisone 200mg or placebo per day for seven days.

Status

The ADRENAL study has completed recruitment. Follow up of patients continue.

ADRENAL has 53 sites in Australia and New Zealand, 3 sites in Saudi Arabia, 1 site in Denmark and 12 sites in the UK. The study is expected to be published later in the 2017.