6/28/23, 12:51 AM Annane Trial Pathway Feedback Search Clinical Topics Home Studies Annane Trial Annane Trial Disease Sepsis and septic shock Trial question What is the role of low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock? Study design Multi-center Double blinded RCT Population Characteristics of study participants 33.0% female N = 300 67.0% male 300 patients (100 female, 200 male) Inclusion criteria: patients with septic shock and relative adrenal insufficiency Key exclusion criteria: pregnancy, acute myocardial infarction, PE, advanced form of cancer or AIDS (AIDS) infection, and contraindication or formal indication for corticosteroids Interventions N=151 hydrocortisone and fludrocortisone (hydrocortisone 50 mg IV every 6 hours and fludrocortisone 50 g PO once daily for 7 days) N=149 placebo (matching placebos for 7 days) Primary outcome https://web.pathway.md/studies/recKhC5H3kscRNUjV 1/2 6/28/23, 12:51 AM Annane Trial Pathway Death 63.0 % 63 53 47.3 % 31.5 % Significant decrease 15.8 % NNT = 10 0.0 % Hydrocortisone and fludrocortisone Placebo Significant decrease in death (53% vs. 63%; HR 0.67, 95% CI 0.47 to 0.95) Secondary outcomes Significant increase in the rate of withdrawal of vasopressor therapy within 28 days (57% vs. 40%; HR 1.91, 95% CI 1.29 to 2.84) Safety outcomes No significant difference in adverse events. Conclusion In patients with septic shock and relative adrenal insufficiency, hydrocortisone and fludrocortisone were superior to placebo with respect to death. Reference Annane D, Sebille 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. Open reference URL https://web.pathway.md/studies/recKhC5H3kscRNUjV 2/2