VItamin C in Thermal injuRY: The VICToRY Trial

NCT04138394 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: VICToRY
• Study Type: interventional
• Target: 666
• Locations: 9 countries
• Sites: 33

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.

Conditions

Shock; Thermal Burn

Outcome Measures

Primary Outcomes (2)

• Persistent Organ Dysfunction + Death

  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)

  at 28 days

• Time to discharge alive from hospital

  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.

  90 days

Other Outcomes (9)

• ICU length of stay

  90 days

• Duration of mechanical ventilation

  90 days

• ICU readmission rate

  90 days

Study Arms (2)

Vitamin C

EXPERIMENTAL

Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours

Drug: Ascorbic Acid

Control group

PLACEBO COMPARATOR

Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.

Drug: placebo

Interventions

Ascorbic Acid DRUG

Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).

Also known as: vitamin C

Vitamin C

placebo DRUG

Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.

Also known as: saline, D5W

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \>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.

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead
• Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany: collaborator

Study Sites (33)

Arizona Burn Center Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

The Ohio State University Medical Center

Ohio City, Ohio, 43210, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

Harborview Medical Center - Seattle

Seattle, Washington, 98104, United States

Location

Ascension Columbia St. Mary's

Milwaukee, Wisconsin, 53211, United States

Location

Grand Hopital de Charleroi

Charleroi, Hainaut, 6280, Belgium

Location

Ghent University Hospital

Ghent, Oost Vlaanderen, 9000, Belgium

Location

Belgium Military Hospital, Military Hospital

Brussels, Belgium

Location

Centre Hospitalier Universitaire de Liege

Liège, Belgium

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A6, Canada

Location

Hamilton General Hospital, Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

Location

Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre de recherche du CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Hospital San Juan de Dios

San José, Provincia de San José, Costa Rica

Location

BG Klinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum St. George

Leipzig, Saxony, 04129, Germany

Location

RWTH Aachen University, Aachen

Aachen, Germany

Location

Merheim Medical Center, Hospitals of Cologne

Cologne, Germany

Location

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Ludwigshafen, Germany

Location

University Hospital Würzburg

Würzburg, Germany

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78290, Mexico

Location

Centro Nacional del Quemado y Cirugías Reconstructivas

Asunción, Paraguay

Location

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Chelsea and Westminster Hospital

Chelsea, London, SW10 9NH, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, Mindelsohn Way, B15 2TH, United Kingdom

Location

St Helens and Knowsley Hospitals NHS Trust

Prescot, L35 5DR, United Kingdom

Location

The Mid Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

Location

MeSH Terms

Conditions

Shock

Interventions

Ascorbic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daren K Heyland, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Daren Heyland, MD, MSc, FRCPC

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: July 24, 2020
• Primary Completion: December 15, 2025
• Study Completion: March 31, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); PA (1); GB (4); US (10); CO (1); DE (6); CA (5); BE (4); TH (1)