VItamin C in Thermal injuRY: The VICToRY Trial (VICToRY)

VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial

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.

Study Overview

• Status: Suspended
• Conditions: Shock; Thermal Burn
• Intervention / Treatment: Drug: placebo; Drug: Ascorbic Acid

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 Type: Interventional
• Enrollment (Estimated): 666
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Belgium Military Hospital, Military Hospital
  • Liège, Belgium
    • Centre hospitalier universitaire de Liege
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6280
      • Grand Hopital De Charleroi
  • Oost Vlaanderen
    • Ghent, Oost Vlaanderen, Belgium, 9000
      • Ghent University Hospital
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A6
      • QEII Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital, Hamilton Health Sciences Corporation
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre de recherche du CHUM
    • Québec, Quebec, Canada, G1J 1Z4
      • CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
• Costa Rica
  • Provincia de San José
    • San José, Provincia de San José, Costa Rica
      • Hospital San Juan de Dios
• Germany
  • Aachen, Germany
    • RWTH Aachen University, Aachen
  • Cologne, Germany
    • Merheim Medical Center, Hospitals of Cologne
  • Ludwigshafen, Germany
    • Berufsgenossenschaftliche Unfallklinik Ludwigshafen
  • Würzburg, Germany
    • University Hospital Wurzburg
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • BG Klinik Tübingen
  • Saxony
    • Leipzig, Saxony, Germany, 04129
      • Klinikum St. George
• Mexico
  • San Luis Potosí
    • San Luis Potosí City, San Luis Potosí, Mexico, 78290
      • Hospital Central Dr. Ignacio Morones Prieto
• Paraguay
  • Asunción, Paraguay
    • Centro Nacional del Quemado y Cirugías Reconstructivas
• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10700
      • Siriraj Hospital, Mahidol University
• United Kingdom
  • Prescot, United Kingdom, L35 5DR
    • St Helens and Knowsley Hospitals NHS Trust
  • Wakefield, United Kingdom
    • The Mid Yorkshire Hospitals NHS Trust
  • London
    • Chelsea, London, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital
  • Mindelsohn Way
    • Birmingham, Mindelsohn Way, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center Valleywise Health
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • Ohio
    • Ohio City, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center - Houston
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center - Seattle
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Columbia St. Mary's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: placebo; Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.; Other Names: saline; D5W
Experimental: Vitamin C; Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours	Drug: Ascorbic Acid; Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).; Other Names: vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Components of PODS+28-day mortality	Mortality at 28 days / Use of inotropes or vasopressors at 28 days / Renal replacement therapy at 28 days / On mechanical ventilation at 28 days.	28 days
POD (persistent organ dysfunction)-free days	All days free from persistent organ dysfunction within the first 28 days after admission	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Duration of time in the ICU	90 days
Duration of mechanical ventilation	Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.	90 days
ICU readmission rate	Incidents of readmission to ICU from within the hospital	90 days
Hospital mortality	Did the patient die in hospital or was the patient discharged?	90 days
Hospital length of stay	Duration of time in the hospital	90 days
Gram negative bacteremia	Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli	90 days
6 month mortality	Is the patient alive or deceased 6 months post admission.	6 months
Health-related quality of life	Administration of the SF-36 questionnaire 6 months post admission	6 months
Health related quality of life	Administration of the Katz-ADL (activities of daily living) questionnaire 6 months post admission. This assessment is scored from 0 - 6 with a higher score indicating better functioning.	6 months
Health related quality of life	Administration of the Lawton-IADL (Instrumental Activities of Daily Living) questionnaire 6 months post admission. This assessment is scored from 0 - 8 with a higher score indicating better functioning.	6 months
Burn related procedures	Frequency of operative procedures for burn care.	90
Blood products given	Type and volume of blood products given.	8 days
Inhalation injury	The presence or absence of smoke inhalation injury and whether confirmed by bronchoscopy.	24 hours

Collaborators and Investigators

• Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
• Collaborators: Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany
• Investigators: Principal Investigator: Daren K Heyland, MD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): December 18, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Ascorbic Acid; Sodium Chloride
• Other Study ID Numbers: VICToRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes