6/28/23, 12:14 AM COIITSS Pathway Feedback Search Clinical Topics Home Studies COIITSS COIITSS Disease Sepsis and septic shock Trial question Is intensive insulin therapy superior to conventional insulin therapy in patients treated with hydrocortisone for septic shock? Study design Multi-center Open label RCT Population Characteristics of study participants 35.0% female N = 509 65.0% male 509 patients (179 female, 330 male) Inclusion criteria: adult patients with septic shock who were treated with hydrocortisone Key exclusion criteria: pregnancy; life expectancy below 24 hours Interventions N=255 intensive insulin therapy (continuous insulin infusion to maintain blood glucose levels between 4-6 mmol/L plus hydrocortisone 50 mg intravenous bolus every 6 hours for 7 days) N=254 conventional insulin therapy (conventional glycemic control plus hydrocortisone 50 mg intravenous bolus every 6 hours for 7 days) Primary outcome Death in hospital 45.9 % 45.9 42.9 34 4 % https://web.pathway.md/studies/recwfsx7eoylEjKJo 1/2 6/28/23, 12:14 AM 34.4 % COIITSS Pathway 22.9 % 11.5 % No significant difference 0.0 % Intensive insulin therapy Conventional insulin therapy No significant difference in death in the hospital (45.9% vs. 42.9%; RR 1.07, 95% CI 0.88 to 1.3) Secondary outcomes No significant difference in median mechanical ventilation-free days within 28 days (10 days vs. 13 days; MD -3, 95% CI -11.71 to 5.71) No significant difference in sequential organ failure assessment score < 8 at day 7 (64.3% vs. 60.6%; AD 3.7%, 95% CI -4.45 to 11.85) Safety outcomes No significant difference in superinfections. Significant difference in severe hypoglycemia (16.4% vs. 7.8%). Conclusion In adult patients with septic shock who were treated with hydrocortisone, intensive insulin therapy was not superior to conventional insulin therapy with respect to death in the hospital. Reference COIITSS Study Investigators, Djillali Annane, Alain Cariou et al. Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):341-8. Open reference URL https://web.pathway.md/studies/recwfsx7eoylEjKJo 2/2