Status:
SUSPENDED
VItamin C in Thermal injuRY: The VICToRY Trial
Lead Sponsor:
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborating Sponsors:
Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany
Conditions:
Shock
Thermal Burn
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 an...
Detailed Description
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 be...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Deep 2nd and/or 3rd degree burns requiring skin grafting
- Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)
Exclusion
- \>24 hours from admission to participating hospital to consent.
- Patients admitted to burn unit \>24 from injury or accident.
- Patients who are moribund (not expected to survive the next 72 hours).
- Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
- Enrollment in another industry sponsored ICU intervention study.
- Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Recent history of kidney stones (within the last year).
- Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT04138394
Start Date
July 24 2020
End Date
March 31 2026
Last Update
October 6 2025
Active Locations (33)
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1
Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States, 85008
2
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
3
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637