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VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
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.
In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death. We aim to conduct a large-scale, multi-center randomized trial to evaluate the effect of high-dose (50mg/kg every 6 hours for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC. Patients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg every 6 hrs for 96 hrs. Patients in the control group will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. This study will be the first large international multi-centre trial examining the effects of high dose intravenous vitamin C in burn patients. It represents a unique collaboration of burn units worldwide that is coordinated by the Clinical Evaluation Research Unit, based in Kingston Ontario Canada, a coordinating center that has demonstrated the ability to run multi-center trials and translate findings into practice.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
The Ohio State University Medical Center
Ohio City, Ohio, United States
University of Texas Health Science Center - Houston
Houston, Texas, United States
Harborview Medical Center - Seattle
Seattle, Washington, United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, United States
Start Date
July 24, 2020
Primary Completion Date
December 15, 2025
Completion Date
March 31, 2026
Last Updated
October 6, 2025
666
ESTIMATED participants
Ascorbic Acid
DRUG
placebo
DRUG
Lead Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators
NCT04419480
NCT07179276
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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