VItamin C in Thermal injuRY: The VICToRY Pilot Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Shock
- Thermal Burn
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Patients will be allocated to receive intravenous vitamin C at 200mg/kg in divided doses, every 6 hrs for 96 hrs. 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.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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 associa...
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 (200mg/kg/day x 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 200mg/kg in divided doses, 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.
Tracking Information
- NCT #
- NCT04138394
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Daren K Heyland, MD Queen's University
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