ADRENAL
Trial question
What is the role of hydrocortisone in patients with septic shock undergoing mechanical ventilation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.2% female
60.8% male
N = 3800
3800 patients (1454 female, 2259 male)
Inclusion criteria: patients with septic shock undergoing mechanical ventilation
Key exclusion criteria: systemic corticosteroids for an indication other than septic shock, etomidate treatment during current hospital admission, severely ill from preexisting disease and likely die within 90 days of randomization, or treatment limitations in place
Interventions
N=1832 hydrocortisone (continuous intravenous infusion at a dose of 200 mg per day for 7 days)
N=1826 placebo (identical, masked 200 mL continuous intravenous infusion for 7 days)
Primary outcome
Death at 90 days
27.9
28.8
28.8 %
21.6 %
14.4 %
7.2 %
0.0 %
Hydrocortisone
Placebo
No significant difference ↔
No significant difference in death at 90 days (27.9% vs. 28.8%; HR 0.95, 95% CI 0.82 to 1.1)
Secondary outcomes
Significant decrease in median time to resolution of shock (3 days vs. 4 days; HR 0.76, 95% CI 0.71 to 0.81)
Significant decrease in median time to discharge from ICU (10 days vs. 12 days; HR 0.86, 95% CI 0.81 to 0.94)
Significant decrease in blood transfusion (37% vs. 41.7%; OR 0.82, 95% CI 0.72 to 0.94)
Safety outcomes
No significant difference in new-onset bacteremia or fungemia.
Significant differences in overall adverse events (1.1% vs. 0.3%, p = 0.009).
Conclusion
In patients with septic shock undergoing mechanical ventilation, hydrocortisone was not superior to placebo with respect to death at 90 days.
Reference
Venkatesh B, Finfer S, Cohen J et al. Adjunctive Glucocorticoid Therapy in Patients with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):797-808.
Open reference URL