VItamin C in Thermal injuRY: The VICToRY Trial
- Registration Number
- NCT04138394
- Lead Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 666
- 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)
- >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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control group placebo Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. Vitamin C Ascorbic Acid Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours
- Primary Outcome Measures
Name Time Method Persistent Organ Dysfunction + Death 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)
Time to discharge alive from hospital 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Ascension Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
Grand Hopital de Charleroi
🇧🇪Charleroi, Hainaut, Belgium
Ghent University Hospital
🇧🇪Ghent, Oost Vlaanderen, Belgium
Belgium Military Hospital, Military Hospital
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire de Liege
🇧🇪Liège, Belgium
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Texas Health Science Center - Houston
🇺🇸Houston, Texas, United States
Harborview Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Arizona Burn Center Valleywise Health
🇺🇸Phoenix, Arizona, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
The Ohio State University Medical Center
🇺🇸Ohio City, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Hamilton General Hospital, Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre
🇨🇦Toronto, Ontario, Canada
Centre de recherche du CHUM
🇨🇦Montréal, Quebec, Canada
CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
🇨🇦Québec, Canada
Hospital San Juan de Dios
🇨🇷San José, Costa Rica
BG Klinik Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Klinikum St. George
🇩🇪Leipzig, Saxonia, Germany
RWTH Aachen University, Aachen
🇩🇪Aachen, Germany
Merheim Medical Center, Hospitals of Cologne
🇩🇪Cologne, Germany
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
🇩🇪Ludwigshafen, Germany
University Hospital Würzburg
🇩🇪Würzburg, Germany
Hospital Central Dr. Ignacio Morones Prieto
🇲🇽San Luis Potosí, Mexico
Centro Nacional del Quemado y Cirugías Reconstructivas
🇵🇾Asunción, Paraguay
Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Chelsea and Westminster Hospital
🇬🇧Chelsea, London, United Kingdom
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, Mindelsohn Way, United Kingdom
St Helens and Knowsley Hospitals NHS Trust
🇬🇧Prescot, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
🇬🇧Wakefield, United Kingdom