6/30/23, 12:37 AM VITAMINS Pathway Feedback Search Clinical Topics Home Studies VITAMINS VITAMINS Disease Sepsis and septic shock Trial question What is the effect of the combination of vitamin C, hydrocortisone, and thiamine among patients with septic shock? Study design Multi-center Open label RCT Population Characteristics of study participants 36.7% female N = 216 63.3% male 216 patients (78 female, 133 male) Inclusion criteria: patients in ICUs fulfilling the Sepsis-3 definition of septic shock Key exclusion criteria: age younger than 18 years, a do-not-resuscitate order, imminent death, diagnosis of septic shock > 24 hours ago, known or suspected disease with a strong indication or contraindication for any of the study drugs, and another indication for hydrocortisone than septic shock Interventions N=109 vitamin C, hydrocortisone and thiamine (vitamin C 1.5 g IV q6h, hydrocortisone 50 mg IV q6h, and thiamine 200 mg IV q12h until shock resolution or up to 10 days) N=107 hydrocortisone (hydrocortisone 50 mg IV q6h, until shock resolution or up to 10 days) Primary outcome Hours alive and vasopressor-free up to day 7 https://web.pathway.md/studies/recOlCzNpoDYeozsW 1/2 6/30/23, 12:37 AM VITAMINS Pathway 124.6 hours 124.6 122.1 93.4 hours 62.3 hours 31.1 hours No significant difference 0.0 hours Vitamin C, hydrocortisone and thiamine Hydrocortisone No significant difference in hours alive and vasopressor-free up to day 7 (122.1 hours vs. 124.6 hours; AD -0.6 hours, 95% CI -8.3 to 7.2) Secondary outcomes No significant difference in death at day 90 (28.6% vs. 24.5%; AD 4.1%, 95% CI -8 to 16.1) No significant difference in cumulative vasopressor-free days at day 28 (25.6 days vs. 25.8 days; AD -0.2 days, 95% CI -1.7 to 1.2) No significant difference in cumulative mechanical ventilation-free days at day 28 (25.3 days vs. 24.8 days; AD 0.4 days, 95% CI -2.6 to 3.4) Safety outcomes No significant differences in adverse events such as fluid overload, gastrointestinal bleeding, or hyperglycemia. Significant difference in the absolute change in SOFA score at day 3 (-2 vs. -1). Conclusion In patients in ICUs fulfilling the Sepsis-3 definition of septic shock, vitamin C, hydrocortisone and thiamine were not superior to hydrocortisone with respect to hours alive and vasopressor-free up to day 7. Reference Tomoko Fujii, Nora Luethi, Paul J Young et al. Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial. JAMA. 2020 Feb 4;323(5):423-431. Open reference URL https://web.pathway.md/studies/recOlCzNpoDYeozsW 2/2