VItamin C in Thermal injuRY: The VICToRY Trial
Purpose
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.
Conditions
- Shock
- Thermal Burn
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Patients will be allocated to receive intravenous vitamin C at 50mg/kg, every 6 hrs for 96 hrs or placebo. We justify this proposed dosing strategy as the proposed dose of vitamin C has been shown to be safe and effective in patients with sepsis and lung injury whereas prior dosing strategies used in the burns literature (66 mg/kg/24 hours) have safety issues and are not long enough in duration. Control group: patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Allocation will be random and concealed and will be blinded to everyone except the pharmacist at each site. The vitamin C will be sourced locally and prepared in a blinded manner by local research pharmacies that will be responsible for preparing study samples and delivering them to the ICU in a blinded fashion. The randomization system, which has proven reliable in several prior RCTs, has a robust audit trail, and will maintain concealment and blinding.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Vitamin C |
Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours |
|
|
Placebo Comparator Control group |
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
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 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.