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

May 15, 2023 updated by: Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

666

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6280
        • Not yet recruiting
        • Grand Hôpital de Charleroi
        • Contact:
        • Principal Investigator:
          • Serge Jennes, MD
    • Oost Vlaanderen
      • Ghent, Oost Vlaanderen, Belgium, 9000
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A6
        • Recruiting
        • QEII Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Jack Rasmussen, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Not yet recruiting
        • Hamilton General Hospital, Hamilton Health Sciences Corporation
        • Principal Investigator:
          • Marc Jeschke, MD
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre
        • Contact:
        • Principal Investigator:
          • Stephanie Mason, MD
    • Quebec
  • Germany
      • Aachen, Germany
      • Cologne, Germany
        • Recruiting
        • Manheim Medical Center, Hospitals of Cologne
        • Contact:
      • Ludwigshafen, Germany
      • Würzburg, Germany
        • Not yet recruiting
        • University Hospital Würzburg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Stoppe, MD
  • Mexico
      • San Luis Potosí, Mexico, 78290
        • Recruiting
        • Hospital Central Dr. Ignacio Morones Prieto
        • Contact:
  • Paraguay
      • Asunción, Paraguay
        • Not yet recruiting
        • Centro Nacional del Quemado y Cirugías Reconstructivas
        • Contact:
  • United Kingdom
      • Prescot, United Kingdom, L35 5DR
      • Wakefield, United Kingdom
    • London
      • Chelsea, London, United Kingdom, SW10 9NH
    • Mindelsohn Way
      • Birmingham, Mindelsohn Way, United Kingdom, B15 2TH
        • Not yet recruiting
        • Queen Elizabeth Hospital Birmingham
        • Contact:
  • United States
    • Arizona
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Ohio
      • Ohio City, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Medical Center
        • Contact:
    • Texas
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center - Seattle
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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)
at 28 days
Time to discharge alive from hospital
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PODS+death
Time Frame: 90 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)
90 days
Time to Discharge Alive
Time Frame: 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.
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: 90 days
Duration of time in the ICU
90 days
Duration of mechanical ventilation
Time Frame: 90 days
Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.
90 days
ICU readmission rate
Time Frame: 90 days
Incidents of readmission to ICU from within the hospital
90 days
Hospital mortality
Time Frame: 90 days
Did the patient die in hospital or was the patient discharged?
90 days
Hospital length of stay
Time Frame: 90 days
Duration of time in the hospital
90 days
Wound healing
Time Frame: 90 days
time-to-95% graft closure
90 days
Gram negative bacteremia
Time Frame: 90 days
Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli
90 days
6 month mortality
Time Frame: 6 months
Is the patient alive or deceased 6 months post admission.
6 months
Health-related quality of life
Time Frame: 6 months
Administration of the SF-36 questionnaire 6 months post admission
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

June 1, 2027

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)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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