ShockPhase 3VICToRYNCT04138394
VItamin C in Thermal injuRY: The VICToRY Trial
A Phase 3 study testing Ascorbic Acid in people with Shock and Thermal Burn, run by Clinical Evaluation Research Unit at Kingston General Hospital at 33 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Thermal Burn
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 666 participants
- Where
- 33 sitesin 9 countries
- Study dates
- 24 Jul 2020to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- >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).
Show all 9Show fewer
- 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.
Trial locations and contacts
33 sites in 9 countries.
33 sites in 9 countries
United States10 sites
Bridgeport Hospital
Bridgeport, Connecticut, 06610
The University of Chicago Medical Center
Chicago, Illinois, 60637
University of Texas Health Science Center - Houston
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, 53211
The Ohio State University Medical Center
Ohio City, Ohio, 43210
Arizona Burn Center Valleywise Health
Phoenix, Arizona, 85008
Harborview Medical Center - Seattle
Seattle, Washington, 98104
Mercy Hospital St. Louis
St Louis, Missouri, 63141
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Germany6 sites
RWTH Aachen University, Aachen
Aachen
Merheim Medical Center, Hospitals of Cologne
Cologne
Klinikum St. George
Leipzig, Saxony, 04129
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Ludwigshafen
BG Klinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
University Hospital Würzburg
Würzburg
Canada5 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A6
Hamilton General Hospital, Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Centre de recherche du CHUM
Montreal, Quebec, H2X 0A9
CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre
Toronto, Ontario, M4N 3M5
Belgium4 sites
Belgium Military Hospital, Military Hospital
Brussels
Grand Hopital de Charleroi
Charleroi, Hainaut, 6280
Ghent University Hospital
Ghent, Oost Vlaanderen, 9000
Centre Hospitalier Universitaire de Liege
Liège
United Kingdom4 sites
Queen Elizabeth Hospital Birmingham
Birmingham, Mindelsohn Way, B15 2TH
Chelsea and Westminster Hospital
Chelsea, London, SW10 9NH
St Helens and Knowsley Hospitals NHS Trust
Prescot, L35 5DR
The Mid Yorkshire Hospitals NHS Trust
Wakefield
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78290
Paraguay1 site
Centro Nacional del Quemado y Cirugías Reconstructivas
Asunción
About this study
Official title: VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
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.
Read the 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.
- Conditions
- Shock, Thermal Burn
- Being tested
- Ascorbic Acid, placebo
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called vitamin C
Patients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).
placeboDrug
Also called saline, D5W
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours Receives: Drug: Ascorbic Acid |
| Control group | Placebo comparator | Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 28 days
Secondary outcomes (3)
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.
Measured: 90 days
Components of PODS+28-day mortality
Mortality at 28 days / Use of inotropes or vasopressors at 28 days / Renal replacement therapy at 28 days / On mechanical ventilation at 28 days.
Measured: 28 days
POD (persistent organ dysfunction)-free days
All days free from persistent organ dysfunction within the first 28 days after admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start24 Jul 2020
- Primary completion18 Dec 2025
- Study completion31 Mar 2026 (estimated)
Why it stopped: After the 1st interim analysis, on the recommendation of the DSMC, the steering committee decided to stop enrollment of new patients. The study is ongoing for the currently enrolled patients. More info to follow when available for public disclosure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients will be allocated to receive intravenous vitamin C at 50mg/kg, every 6 hrs for 96 hrs or placebo. We justify this proposed dosing strategy as the proposed dose of vitamin C has been shown to be safe and effective in patients with sepsis and lung injury whereas prior dosing strategies used in the burns literature (66 mg/kg/24 hours) have safety issues and are not long enough in duration. Control group: patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Responsible party
- Principal investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren K Heyland, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138394
- Sponsor's protocol ID
- VICToRY
- Acronym
- VICToRY
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoppe C, Hill A, Cancio LC, Day AG, Pruskowski KA, Turgeon AF, Pham T, Belisle S, Martinez-Jimenez MA, Limper U, Gille J, Wisler J, Savetamal A, Pollack J, Grau Dominguez D, Jennes S, Shupp JW, Jeschke MG, Colpaert K, Hundeshagen G, Beier JP, Muangman P, Echeverri McCandless A, Meybohm P, Grune T, Dresen E, Weber D, Guttler C, Lew CCH, Jiang X, Froese S, Dansereau M, Lee ZY, Heyland DK; VICTORY Study Team. High-Dose Intravenous Vitamin C and Mortality and Organ Dysfunction in Severe Burn Injury: The VICTORY Randomized Clinical Trial. JAMA. 2026 Jun 10:e2610616. doi: 10.1001/jama.2026.10616. Online ahead of print.
PubMed 42267875
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT04138394
- Acronym / sponsor ID
- VICToRY / VICToRY
- Conditions
- Shock, Thermal Burn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: After the 1st interim analysis, on the recommendation of the DSMC, the steering committee decided to stop enrollment of new patients. The study is ongoing for the currently enrolled patients. More info to follow when available for public disclosure.
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be allocated to receive intravenous vitamin C at 50mg/kg, every 6 hrs for 96 hrs or placebo. We justify this proposed dosing strategy as the proposed dose of vitamin C has been shown to be safe and effective in patients with sepsis and lung injury whereas prior dosing strategies used in the burns literature (66 mg/kg/24 hours) have safety issues and are not long enough in duration. Control group: patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Ascorbic AcidPatients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours |
| Control group | Placebo comparator | Drug: placeboPatients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: vitamin CPatients will receive intravenous vitamin C (50 mg/kg every 6 hours for 96 hours). | Drug | Vitamin C |
| placeboAlso: saline, D5WPatients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. | Drug | Control group |
Primary outcome
Persistent Organ Dysfunction + Death
Time frame: 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)
3 secondary outcomes
Time to discharge alive from hospital
Time frame: 90 days
Components of PODS+28-day mortality
Time frame: 28 days
POD (persistent organ dysfunction)-free days
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 42267875Stoppe C, Hill A, Cancio LC, Day AG, Pruskowski KA, Turgeon AF, Pham T, Belisle S, Martinez-Jimenez MA, Limper U, Gille J, Wisler J, Savetamal A, Pollack J, Grau Dominguez D, Jennes S, Shupp JW, Jeschke MG, Colpaert K, Hundeshagen G, Beier JP, Muangman P, Echeverri McCandless A, Meybohm P, Grune T, Dresen E, Weber D, Guttler C, Lew CCH, Jiang X, Froese S, Dansereau M, Lee ZY, Heyland DK; VICTORY Study Team. High-Dose Intravenous Vitamin C and Mortality and Organ Dysfunction in Severe Burn Injury: The VICTORY Randomized Clinical Trial. JAMA. 2026 Jun 10:e2610616. doi: 10.1001/jama.2026.10616. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren K Heyland, MD principal investigator
Queen's University
33 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ascorbic Acid in people with Shock and Thermal Burn, run by Clinical Evaluation Research Unit at Kingston General Hospital at 33 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Canada, Belgium, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Organ Dysfunction + Death (time frame: at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.