High-Dose Intravenous Vitamin C and Mortality and Organ Dysfunction in Severe Burn Injury: The VICTORY Randomized Clinical Trial.
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Stoppe Christian, Hill Aileen, Cancio Leopoldo C, Day Andrew G, Pruskowski Kaitlin A, Turgeon Alexis F, Pham Tam, Bélisle Sylvain, Martínez-Jiménez Mario Aurelio, Limper Ulrich, Gille Jochen, Wisler Jon, Savetamal Alisa, Pollack Jonathan, Grau Domínguez Daisy, Jennes Serge, Shupp Jeffrey W, Jeschke Marc G, Colpaert Kirsten, Hundeshagen Gabriel, Beier Justus P, Muangman Pornprom, Echeverri McCandless Ann, Meybohm Patrick, Grune Tilman, Dresen Ellen, Weber Daniela, Güttler Carina, Lew Charles Chin Han, Jiang Xuran, Froese Shawna, Dansereau Maureen, Lee Zheng-Yii, Heyland Daren K, VICTORY Study Team
Аннотация
OBJECTIVE: To evaluate the efficacy of high-dose intravenous vitamin C in patients with severe burn injury.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled phase 3 trial conducted across 24 burn centers in North, Central, and South America; Europe; and Asia. Adults (≥18 years) with deep second- and/or third-degree burns covering 20% or more of total body surface area and requiring skin grafting were enrolled between August 18, 2020, and September 12, 2025. Final follow-up was completed in March 2026. The trial was stopped early after the first prespecified interim analysis for futility/harm.
INTERVENTIONS: Patients were randomly assigned (1:1) to receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours) or matched placebo.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of 28-day mortality and persistent organ dysfunction (defined as dependence on mechanical ventilation, kidney replacement therapy, or vasopressor/inotrope support at day 28). The main secondary outcome was time to discharge alive from hospital within 90 days.
RESULTS: Among 238 patients enrolled (mean age, 48.9 [SD, 19.1] years; 79% male; mean total body surface area, 37.0% [SD, 14.6%]), 120 were assigned to vitamin C and 118 to placebo. The primary composite outcome occurred in 49 patients (40.8%) in the vitamin C group and 35 patients (29.7%) in the placebo group (adjusted risk ratio [RR], 1.28 [95% CI, 0.99-1.65]; P = .06), crossing the prespecified futility/harm threshold and prompting early trial termination. Time to discharge alive from hospital within 90 days was not improved (adjusted subdistribution hazard ratio, 0.85 [95% CI, 0.62-1.16]; P = .31). Twenty-eight-day mortality was higher in the vitamin C group (15.0% vs 7.6%; adjusted RR, 1.96 [95% CI, 1.32-2.90]; P = .001), as was hospital mortality (23.3% vs 16.1%; adjusted RR, 1.44 [95% CI, 1.03-2.00]; P = .03).
CONCLUSIONS AND RELEVANCE: Among patients with severe burn injury, high-dose intravenous vitamin C did not reduce 28-day mortality and persistent organ dysfunction and is possibly harmful.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04138394.