Francois Lamontagne, MD, MSc; Maureen O. Meade, MD, MSc
Is low-dose hydrocortisone effective and safe for septic shock?
Randomized placebo-controlled trial (Corticosteroid Therapy of Septic Shock [CORTICUS]).
Blinded (clinicians, patients, investigators, pharmacists, data collectors, outcome assessors, monitoring committee, and clinical evaluation committee).*
52 intensive care units (ICUs) in Israel and Europe.
500 patients ≥ 18 years of age (mean age 63 y, 67% men) admitted to the ICU with clinical evidence of infection, systemic response to infection, and onset of shock in the past 72 hours. Exclusion criteria included underlying disease with a poor prognosis, life expectancy < 24 hours, immunosuppression, and recent treatment with corticosteroids.
Hydrocortisone, 50-mg IV bolus every 6 hours for 5 days, then tapered over the next 6 d (total 29 doses) (n = 252) or placebo (n = 248).
Death at 28 days, in the ICU, and at 1 year; and reversal of shock at 28 days.
95% at 1 year (intention-to-treat analysis).
Hydrocortisone did not differ from placebo for death at any time point; results were similar in a prespecified subgroup analysis based on corticotropin test response (Table). Groups did not differ for proportion for shock reversal (Table), but time to reversal was shorter in the hydrocortisone group (median 3.3 vs 5.8 d, P < 0.001). Risks for new septic shock (6.0% vs 2.2%), hyperglycemia (85% vs 72%), and hypernatremia (29% vs 18%) increased with hydrocortisone; groups did not differ for superinfection (33% vs 26%).
In septic shock, low-dose hydrocortisone shortened time to shock reversal but did not increase survival or shock reversal and increased complications. Response to corticotropin testing did not influence treatment effect.
Low-dose hydrocortisone vs placebo for septic shock†
†ICU = intensive care unit; other abbreviations defined in Glossary. RRI, RBI, and CI calculated from data in article. All results were statistically nonsignificant.
Lamontagne F, Meade MO. Low-dose hydrocortisone did not improve survival in patients with septic shock but reversed shock earlier. Ann Intern Med. ;148:JC4–6. doi: 10.7326/0003-4819-148-12-200806170-02006
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Published: Ann Intern Med. 2008;148(12):JC4-6.
Multi-Organ Failure and Sepsis, Pulmonary/Critical Care.
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