SUSPENDED

VItamin C in Thermal injuRY: The VICToRY Trial

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Conditions

ShockThermal Burn

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-07-24
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04138394

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Deep 2nd and/or 3rd degree burns requiring skin grafting
  3. * Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)
  1. * \>24 hours from admission to participating hospital to consent.
  2. * Patients admitted to burn unit \>24 from injury or accident.
  3. * Patients who are moribund (not expected to survive the next 72 hours).
  4. * Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
  5. * Enrollment in another industry sponsored ICU intervention study.
  6. * Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
  7. * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  8. * Recent history of kidney stones (within the last year).
  9. * Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.

Contacts and Locations

Principal Investigator

Daren K Heyland, MD
PRINCIPAL_INVESTIGATOR
Queen's University

Study Locations (Sites)

Arizona Burn Center Valleywise Health
Phoenix, Arizona, 85008
United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141
United States
The Ohio State University Medical Center
Ohio City, Ohio, 43210
United States
University of Texas Health Science Center - Houston
Houston, Texas, 77030
United States
Harborview Medical Center - Seattle
Seattle, Washington, 98104
United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, 53211
United States

Collaborators and Investigators

Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

  • Daren K Heyland, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2020-07-24
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2020-07-24
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Shock
  • Thermal Burn