VItamin C in Thermal injuRY: The VICToRY Trial

Last updated: June 14, 2024
Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Low Blood Pressure (Hypotension)

Treatment

placebo

Ascorbic Acid

Clinical Study ID

NCT04138394
VICToRY
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 666
Treatment Group(s): 2
Primary Treatment: placebo
Phase: 3
Study Start date:
July 24, 2020
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Grand Hopital de Charleroi

    Charleroi, Hainaut 6280
    Belgium

    Active - Recruiting

  • Ghent University Hospital

    Ghent, Oost Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Belgium Military Hospital, Military Hospital

    Brussels,
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege

    Liège,
    Belgium

    Site Not Available

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 3A6
    Canada

    Active - Recruiting

  • Hamilton General Hospital, Hamilton Health Sciences Corporation

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Centre de recherche du CHUM

    Montréal, Quebec H2X 0A9
    Canada

    Active - Recruiting

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

    Québec, G1J 1Z4
    Canada

    Active - Recruiting

  • CHU de Québec-Université Laval, Hôpital de lènfant Jésus

    Québec, G1J 1Z4
    Canada

    Active - Recruiting

  • Hospital San Juan de Dios

    San José,
    Costa Rica

    Active - Recruiting

  • BG Klinik Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • Klinikum St. George

    Leipzig, Saxonia 04129
    Germany

    Active - Recruiting

  • RWTH Aachen University, Aachen

    Aachen,
    Germany

    Active - Recruiting

  • Manheim Medical Center, Hospitals of Cologne

    Cologne,
    Germany

    Active - Recruiting

  • Merheim Medical Center, Hospitals of Cologne

    Cologne,
    Germany

    Active - Recruiting

  • Berufsgenossenschaftliche Unfallklinik Ludwigshafen

    Ludwigshafen,
    Germany

    Active - Recruiting

  • University Hospital Würzburg

    Würzburg,
    Germany

    Site Not Available

  • Instituto Nacional de Rehabilitacion

    Mexico City, 14389
    Mexico

    Site Not Available

  • Hospital Central Dr. Ignacio Morones Prieto

    San Luis Potosí, 78290
    Mexico

    Active - Recruiting

  • Centro Nacional del Quemado y Cirugías Reconstructivas

    Asunción,
    Paraguay

    Active - Recruiting

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Chelsea and Westminster Hospital

    Chelsea, London SW10 9NH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham

    Birmingham, Mindelsohn Way B15 2TH
    United Kingdom

    Site Not Available

  • St Helens and Knowsley Hospitals NHS Trust

    Prescot, L35 5DR
    United Kingdom

    Site Not Available

  • The Mid Yorkshire Hospitals NHS Trust

    Wakefield,
    United Kingdom

    Site Not Available

  • Arizona Burn Center Valleywise Health

    Phoenix, Arizona 85008
    United States

    Active - Recruiting

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Tampa General Hospital-USF

    Tampa, Florida 33606
    United States

    Site Not Available

  • Joseph M Still RF, Doctors Hospital

    Augusta, Georgia 30909
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mercy Hospital St. Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • The Ohio State University Medical Center

    Ohio City, Ohio 43210
    United States

    Active - Recruiting

  • Southwestern Medical Center - University of Texas

    Dallas, Texas 75390-8507
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390-8507
    United States

    Active - Recruiting

  • University of Texas Health Science Center - Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Harborview Medical Center - Seattle

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.