drugset / Trial / NCT04138394

VItamin C in Thermal injuRY: The VICToRY Trial

NCT04138394 ↗

RandomizedSingle-groupQuadruple-blindTreatment

Summary

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

Timeline

Start
2020-07-24
Primary completion
2025-12-18
Completion
2026-03-31

Outcome

Missed primary endpoint

Stopped (Enrollment): “After the 1st interim analysis, on the recommendation of the DSMC, the steering committee decided to stop enrollment of new patients. The study is ongoing for the currently enrolled patients. More info to follow when available for public disclosure.”

paper The primary composite outcome occurred in 49 patients (40.8%) in the vitamin C group and 35 patients (29.7%) in the placebo group PMID 42267875 ↗

paper adjusted risk ratio [RR], 1.28 [95% CI, 0.99-1.65]; P = .06 PMID 42267875 ↗

paper high-dose intravenous vitamin C did not reduce 28-day mortality and persistent organ dysfunction PMID 42267875 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 50 mg/kg Intravenous

Indications

No indication recorded.