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

Abstract

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.MethodsIn 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.ConclusionIntravenous 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).