GuARDS
Glucocorticoids in adults with Acute Respiratory Distress Syndrome trial
A randomised, parallel-group, allocation-concealed, open label, pragmatic, group sequential design, clinical and cost-effectiveness trial
Aim:
To investigate the effect of dexamethasone versus no dexamethasone on 60-day mortality in adult patients with acute respiratory distress syndrome (ARDS) with moderate-to-severe hypoxaemia.
Rationale:
Critically ill patients are often mechanically ventilated, and in this group, around 10% will have ARDS. ARDS is a severe, acute, diffuse, inflammatory lung injury, that leads to increased pulmonary vascular permeability, loss of aerated lung tissue, decreased lung compliance, and hypoxaemia. ARDS affects all age groups, has a mortality rate around 40%, and survivors frequently experience exercise limitations, psychological sequelae, decreased physical quality of life and difficulties returning to work. Despite more than 50 years of research, there is no pharmacological therapy associated with improved outcomes in patients with ARDS. Among several therapies, glucocorticoids are the most promising.
Study Progress:
Ethics approval obtained through the Nepean Blue Mountains HREC on 8th December 2025. The aim is to commence recruitment in Australia in early 2026. A total of 1586 patients will be enrolled internationally.
Funding:
$1,894,125 was awarded through the MRFF Clinical Trials Activity scheme.
Data Entry Webpage:
https://redcap.helix.monash.edu/redcap_v15.0.32/index.php?pid=3689
Trial Registration:
The study has been registered with the ISRCTN; ISRCTN15076735.