High-dose vitamin C for critically ill burn patients
VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
This study is testing if high-dose vitamin C can help critically ill burn patients recover better and live longer compared to those who receive standard care alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 666 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Evaluation Research Unit at Kingston General Hospital Academic / other |
| Locations | 34 sites (Phoenix, Arizona and 33 other locations) |
| Trial ID | NCT04138394 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of high-dose intravenous vitamin C on critically ill patients with severe burns. Participants will receive either vitamin C or a placebo in addition to standard care, with the aim of reducing organ dysfunction and improving survival rates. The study will be conducted across multiple centers internationally, making it one of the largest trials of its kind. The primary outcome will assess the rate of persistent organ dysfunction and all-cause mortality over a 28-day period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with deep second or third-degree burns covering at least 20% of their total body surface area.
Not a fit: Patients who are moribund or have severe comorbidities that preclude survival are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and survival rates for patients with severe burns.
How similar studies have performed: While this approach is novel in the context of severe burns, previous studies have suggested potential benefits of vitamin C in critical illness, indicating a promising area of exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * \>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.
Where this trial is running
Phoenix, Arizona and 33 other locations
- Arizona Burn Center Valleywise Health — Phoenix, Arizona, United States (Completed)
- Bridgeport Hospital — Bridgeport, Connecticut, United States (Recruiting)
- MedStar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
- The University of Chicago Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (Completed)
- Mercy Hospital St. Louis — Saint Louis, Missouri, United States (Recruiting)
- The Ohio State University Medical Center — Ohio City, Ohio, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Withdrawn)
- University of Texas Health Science Center - Houston — Houston, Texas, United States (Recruiting)
- Harborview Medical Center - Seattle — Seattle, Washington, United States (Recruiting)
- Ascension Columbia St. Mary's — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
- Grand Hopital de Charleroi — Charleroi, Hainaut, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Oost Vlaanderen, Belgium (Recruiting)
- Belgium Military Hospital, Military Hospital — Brussels, Belgium (Not_yet_recruiting)
- Centre Hospitalier Universitaire de Liege — Liège, Belgium (Not_yet_recruiting)
- QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Hamilton General Hospital, Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- Centre de recherche du CHUM — Montréal, Quebec, Canada (Recruiting)
- CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus — Québec, Canada (Recruiting)
- Hospital San Juan de Dios — San José, Costa Rica (Recruiting)
- BG Klinik Tübingen — Tübingen, Baden-Württemberg, Germany (Active_not_recruiting)
- Klinikum St. George — Leipzig, Saxonia, Germany (Recruiting)
- RWTH Aachen University, Aachen — Aachen, Germany (Recruiting)
- Merheim Medical Center, Hospitals of Cologne — Cologne, Germany (Recruiting)
- Berufsgenossenschaftliche Unfallklinik Ludwigshafen — Ludwigshafen, Germany (Recruiting)
- University Hospital Würzburg — Würzburg, Germany (Not_yet_recruiting)
- Hospital Central Dr. Ignacio Morones Prieto — San Luis Potosí, Mexico (Recruiting)
- Centro Nacional del Quemado y Cirugías Reconstructivas — Asunción, Paraguay (Recruiting)
- Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
- Chelsea and Westminster Hospital — Chelsea, London, United Kingdom (Not_yet_recruiting)
- Queen Elizabeth Hospital Birmingham — Birmingham, Mindelsohn Way, United Kingdom (Not_yet_recruiting)
- St Helens and Knowsley Hospitals NHS Trust — Prescot, United Kingdom (Not_yet_recruiting)
- The Mid Yorkshire Hospitals NHS Trust — Wakefield, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Daren K Heyland, MD — Queen's University
- Study coordinator: Maureen Dansereau
- Email: maureen.dansereau@queensu.ca
- Phone: 613-888-4320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.