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Summary of the Annane 2002 Trial
Among patients with very early septic shock who were non-responders to a cosyntropin stim test, hydrocortisone/fludrocortisone therapy improved 28-day survival. Furthermore, steroid therapy reduced duration of vasopressor therapy in all patients (regardless of stim test response).
Key Points from Annane 2002
- Included 299 patients with septic shock and mechanical ventilation within 3-8 hours of meeting study criteria (CORTICUS enrolled within 72 hours)
- Compared placebo vs. hydrocortisone 50 mg IV Q6h + fludrocortisone 50 mcg PO daily x 7 days (no taper)
- All patients were stim tested (250 mcg cosyntropin) and classified as “responders” or “non-responders” (less than 9 mcg/dL increase in cortisol)
- Primary endpoint (28-day survival among non-responders) was reduced with steroid therapy (63% vs. 53%, p=0.04, NNT=10)
- No clinical effect seen in responders, but cohort was underpowered (N=70, 23% entire study)
Steroid therapy reduced median duration of vasopressor therapy (9 vs. 7 days, p=0.01)
- Over 80% of screened patients were ineligible for study inclusion (1026 of 1326 screened), many due to very quick enrollment period from onset of septic shock — limits external validity
Annane D, Sébille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. PMID 12186604