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Hydrocortisone Therapy for Patients with Septic shock
Hydrocortisone Therapy for Patients with Septic shock Presented by R2 柯維琦 Supervised by V.S. 陳欽明 Background The use of corticosteroids in severe sepsis and septic shock as an adjunctive therapy is controversial. Low dose corticosteroids (200-300mg/day) has reported earlier reversal of shock and improved survival. Or increase in superinfection related mortality. Especially patients showed no response to corticotropin test. Corticosteroid Therapy of Septic Shock (Corticus) study To evaluate the efficacy and safety of low dose hydrocortisone therapy in patients with septic shock Methods Multicenter, randomized, double-blind, placebo- controlled study. Period – March 2002 to November 2005 Patients Inclusion criteria Exclusion criteria Randomization and Study Drugs Computerized random-number generator list In 1:1 ratio Sealed boxes of study drugs Study drug – Hydrocortisone (Rotexmedica) Dosage – 50mg q6h for day 1-5, 50mg q12h for day 6-8, 50mg qd for day 9-11, and off Definitions Organ-system failure - SOFA score 3 or 4 Reversal of shock - SBP of at least 90 mmHg for at least 24 hours Superinfection - a new infection occurring 48 hours or more after the initiation of a study drug New sepsis - a new septic episode with or without microbiologic confirmation New septic shock – a new episode of septic shock after reversal of initial episode Absence of response to a corticotropin test – an increase in the cortisol level of no more than 9μg/dl Data collection Clinical evaluation Laboratory Measures Follow-up End-points Statistical Analysis Clinical Evaluation General characteristics of patients - demographic data, diagnoses, recent surgery The severity of illness -
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