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Summary of the CORTICUS Trial (Sprung 2008)
Hydrocortisone therapy did not improve outcomes among patients with septic shock (onset within 72 hours), although it did shorten the duration of vasopressor dependence.
Key Points from CORTICUS (Sprung 2008)
- Included 499 patients with septic shock within the past 72 hours. (Annane 2002 enrolled patients within 8 hours of shock)
- Randomized patients to placebo or hydrocortisone (without fludrocortisone)
- All patients received a stim test. Non-responders were those with < 9 mcg/dL increase in serum cortisol at 60 minutes
- Hydrocortisone regimen: 50 mg IV Q6h x 5 days, then 50 mg IV Q12h (days 6-8), then 50 mg IV Q24h (days 9-11), then stop
- Primary endpoint (28-day mortality among non-responders) was not different between hydrocortisone or placebo (39.2% vs. 36.1%, p=0.69)
- Mortality among responders was not different (28.8% vs. 28.7%, p=1.00)
- Time to reversal of shock (SBP > 90 mmHg without vasopressors for at least 24 hrs) was quicker with hydrocortisone (3.3 vs. 5.8 days) for both responders and non-responders
- Patients receiving hydrocortisone had a higher incidence of new infections occurring 48+ hrs after study drug (OR 1.37, 95% CI 1.05 to 1.79), hyperglycemia, and hypernatremia
- Study was underpowered for the primary endpoint (only enrolling 499 of a projected 800 for adequate power). Given the lack of effect seen, study is at high risk for type-II error
Sprung CL, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. PMID 18184957