Shock Clinical Trial
— VICToRYOfficial title:
VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
NCT number | NCT04138394 |
Other study ID # | VICToRY |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 24, 2020 |
Est. completion date | June 2027 |
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.
Status | Recruiting |
Enrollment | 666 |
Est. completion date | June 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Belgium Military Hospital, Military Hospital | Brussels | |
Belgium | Grand Hopital de Charleroi | Charleroi | Hainaut |
Belgium | Ghent University Hospital | Ghent | Oost Vlaanderen |
Belgium | Centre Hospitalier Universitaire de Liege | Liège | |
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Hamilton General Hospital, Hamilton Health Sciences Corporation | Hamilton | Ontario |
Canada | Centre de recherche du CHUM | Montréal | Quebec |
Canada | CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus | Québec | |
Canada | Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre | Toronto | Ontario |
Costa Rica | Hospital San Juan de Dios | San José | |
Germany | RWTH Aachen University, Aachen | Aachen | |
Germany | Merheim Medical Center, Hospitals of Cologne | Cologne | |
Germany | Klinikum St. George | Leipzig | Saxonia |
Germany | Berufsgenossenschaftliche Unfallklinik Ludwigshafen | Ludwigshafen | |
Germany | BG Klinik Tübingen | Tübingen | Baden-Württemberg |
Germany | University Hospital Würzburg | Würzburg | |
Mexico | Hospital Central Dr. Ignacio Morones Prieto | San Luis Potosí | |
Paraguay | Centro Nacional del Quemado y Cirugías Reconstructivas | Asunción | |
Thailand | Siriraj Hospital, Mahidol University | Bangkok | |
United Kingdom | Queen Elizabeth Hospital Birmingham | Birmingham | Mindelsohn Way |
United Kingdom | Chelsea and Westminster Hospital | Chelsea | London |
United Kingdom | St Helens and Knowsley Hospitals NHS Trust | Prescot | |
United Kingdom | The Mid Yorkshire Hospitals NHS Trust | Wakefield | |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | University of Texas Health Science Center - Houston | Houston | Texas |
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | Ascension Columbia St. Mary's | Milwaukee | Wisconsin |
United States | The Ohio State University Medical Center | Ohio City | Ohio |
United States | Arizona Burn Center Valleywise Health | Phoenix | Arizona |
United States | Mercy Hospital St. Louis | Saint Louis | Missouri |
United States | Harborview Medical Center - Seattle | Seattle | Washington |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Clinical Evaluation Research Unit at Kingston General Hospital | Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany |
United States, Belgium, Canada, Costa Rica, Germany, Mexico, Paraguay, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ICU length of stay | Duration of time in the ICU | 90 days | |
Other | Duration of mechanical ventilation | Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge. | 90 days | |
Other | ICU readmission rate | Incidents of readmission to ICU from within the hospital | 90 days | |
Other | Hospital mortality | Did the patient die in hospital or was the patient discharged? | 90 days | |
Other | Hospital length of stay | Duration of time in the hospital | 90 days | |
Other | Wound healing | time-to-95% graft closure | 90 days | |
Other | Gram negative bacteremia | Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli | 90 days | |
Other | 6 month mortality | Is the patient alive or deceased 6 months post admission. | 6 months | |
Other | Health-related quality of life | Administration of the SF-36 questionnaire 6 months post admission | 6 months | |
Primary | 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 | |
Primary | 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 |
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