CORTICUS
Trial question
What is the role of hydrocortisone therapy in patients with septic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 499
499 patients (167 female, 332 male).
Inclusion criteria: patients with septic shock.
Key exclusion criteria: underlying disease with a poor prognosis, a life expectancy of < 24 hours, immunosuppression, and treatment with long-term corticosteroids within the past 6 months or short-term corticosteroids within the past 4 weeks.
Interventions
N=251 hydrocortisone (intravenous 50 mg every 6 hours for 5 days).
N=248 placebo (identical placebo intravenous every 6 hours for 5 days).
Primary outcome
Death at 28 days, among corticotropin non-responders
39.2%
36.1%
39.2 %
29.4 %
19.6 %
9.8 %
0.0 %
Hydrocortisone
Placebo
No significant
difference ↔
No significant difference in death at 28 days, among corticotropin non-responders (39.2% vs. 36.1%; RR 1.09, 95% CI 0.77 to 1.52).
Secondary outcomes
No significant difference in death at 28 days, among corticotropin responders (28.8% vs. 28.7%; RR 1, 95% CI 0.68 to 1.49).
No significant difference in death at 28 days (34.3% vs. 31.5%; RR 1.09, 95% CI 0.84 to 1.41).
Significantly shorter time to reversal of shock (3.3 days vs. 5.8 days; AD -2.5 days, 95% CI -3.98 to -1.02).
Safety outcomes
Significant differences in new sepsis (3% vs. 1%), new shock (6% vs. 2%), new hyperglycemia (85% vs. 72%), and new hypernatremia (29% vs. 18%).
Conclusion
In patients with septic shock, hydrocortisone was not superior to placebo with respect to death at 28 days, among corticotropin non-responders.
Reference
Charles L Sprung, Djillali Annane, Didier Keh et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24.
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