Vitamin C Versus Placebo in Pediatric Septic Shock (VITACiPS) - A Randomised Controlled Trial

Background: Intravenous vitamin C has been evaluated as an adjunctive therapy in adults with septic shock, with mixed results. In pediatric patients, evidence remains limited and its role is yet to be defined. Methods: In this randomized, double-blind, placebo-controlled trial conducted in the pediatric intensive care unit (PICU) of a tertiary care hospital from February 2022 to March 2024, children <17 years-old with septic shock were randomly assigned to receive either intravenous Vitamin C at 25 mg/kg every 6 h for 72 h or equal volumes of 5% dextrose as placebo. The primary outcome was change in pediatric sequential organ failure assessment (pSOFA) score at 72 h from baseline. Secondary outcome was shock resolution and 28-day mortality. Results: Of 262 children with septic shock, 218 were randomized [median (IQR) age: 96 months (36.5, 133); 128 male]. The adjusted mean difference for change in pSOFA score at 72 h between the Vitamin C and placebo groups was -0.51 [95% CI: (-1.76, 0.75)] (p = 0.43)] (reduction in the Vitamin C group as compared to the placebo group). The 28-day mortality was comparable [Vitamin C, 21.6% versus placebo, 22.5%, RR: 0.96 (0.58-1.58), p = 0.88]. There was no difference in shock resolution or any other outcomes. The incidence of prespecified adverse events (acute kidney injury) was similar in both groups. Conclusion Intravenous Vitamin C administration as adjunctive therapy in pediatric septic shock did not significantly impact organ dysfunction at 72 h. Our findings do not support the routine use of Vitamin C as adjunctive therapy in septic shock in children.Trial registration: Clinical trial registry India (CTRI/2020/01/022886).