VItamin C in Thermal injuRY: The VICToRY Trial

Shock Clinical Trial

— VICToRY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138394
• Other study ID #: VICToRY
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Shock
• Thermal Burn

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