VItamin C in Thermal injuRY: The VICToRY Trial

Phase 3

Recruiting

• Conditions: Thermal Burn; Shock
• Interventions: Drug: placebo; Drug: Ascorbic Acid

• Registration Number: NCT04138394
• Lead Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2020-07-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 666

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	placebo	Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
Vitamin C	Ascorbic Acid	Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours

Primary Outcome Measures

Name	Time	Method
Persistent Organ Dysfunction + Death	at 28 days	Persistent organ dysfunction (PODS)+death, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation)
Time to discharge alive from hospital	90 days	Time to discharge alive from hospital, a composite of mortality and length of stay is similar to "ventilator- free days", which is a widely accepted and commonly used outcome in intensive care research.

Trial Locations

Locations (34)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Arizona Burn Center Valleywise Health; 🇺🇸 Phoenix, Arizona, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States

Mercy Hospital St. Louis; 🇺🇸 Saint Louis, Missouri, United States

The Ohio State University Medical Center; 🇺🇸 Ohio City, Ohio, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Texas Health Science Center - Houston; 🇺🇸 Houston, Texas, United States

Harborview Medical Center - Seattle; 🇺🇸 Seattle, Washington, United States

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