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VItamin C in Thermal injuRY: The VICToRY Trial A phase III multi-center randomized trial
EU CTIS ID: 2023-504772-21-00
What this study is testing
In patients with severe, life-threatening burn injury, what is the effect of high dose (50 mg/kg every 6 h hrs 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?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size ≥ 20% Total Body Surface Area (TBSA). Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).
You likely can't join if
- >24 hrs 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.
- Enrolment in another industry sponsored intensive care unit (ICU) intervention study.
- Receiving high-dose intravenous (IV) vitamin C already (enteral or oral vitamin C is allowed).
See the full eligibility criteria
- 18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size ≥ 20% Total Body Surface Area (TBSA). Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).
- >24 hrs 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.
- Enrolment in another industry sponsored intensive care unit (ICU) intervention study.
- Receiving high-dose intravenous (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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Mexico
- United States
- Canada
- Paraguay
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Mexico; United States; Canada; Paraguay. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.