VItamin C in Thermal injuRY: The VICToRY Trial

Clinical Evaluation Research Unit at Kingston General Hospital

Status and phase

Enrolling

Phase 3

Conditions

Thermal Burn

Shock

Treatments

Drug: placebo

Drug: Ascorbic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04138394

VICToRY

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

666 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.