VITAMINS Trial: Vitamin C, hydrocortisone, and thiamine in Septic Shock

vitamins trial visual summary

2021 2021 VITAMINS TRIAL M Effect of Vitamin C, hydrocortisone, and thiamine vs hydrocortisone alone on time alive and free of vasopressor support among patients with septic shock Open label, multi-centre, randomized, phase IIb clinical trial Objective: To investigate whether treatment with Vitamin C, hydrocortisone & thiamine (intervention) lead to a more rapid resolution of septic shock compared with hydrocortisone alone (control) 211 Inclusion criteria: patients had suspected or documented infection with an acute increase of at least 2 points in the SOFA score, had a lactate level > 2 mmol/L, and were vasopressor dependent for at least 2 hours. patients Intervention group (n = 107) Control group (n = 104) PRIMARY OUTCOME 122.1 Time alive and free of vasopressors (in hours) Diff -0.6; 95% CI, -8.3 to 7.2; P=0.83 124.6 SECONDARY OUTCOME Change in SOFA score at day 3 Diff -0.1; 95% CI, -1.9 to -0.1; P=0.02 24 28-days mortality % Diff 2.3; 95% CI, -8.9 to 13.4; P=0.69 21 Conclusion: In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. T Fujii et al. JAMA 2020;323(5):423-431