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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source Clinical Evaluation Research Unit at Kingston General Hospital
Contact Maureen Dansereau
Phone 613-888-4320
Email maureen.dansereau@queensu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ascorbic Acid
Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).
placebo
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Clinical Evaluation Research Unit at Kingston General Hospital Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, Germany

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Costa Rica,  Germany,  Mexico,  Paraguay,  Thailand,  United Kingdom, 

Outcome

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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