VItamin C in Thermal injuRY: The VICToRY Trial A phase III multi-center randomized trial

Phase 1

Recruiting

Conditions: Severely burned patients
MedDRA version: 20.0Level: LLTClassification code: 10006634Term: Burn Class: 10022117
Therapeutic area: Diseases [C] - Disorders of Environmental Origin [C21]

Registration Number: CTIS2023-504772-21-00

Lead Sponsor: Queen's University At Kingston

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 373

Inclusion Criteria

18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size = 20% Total Body Surface Area (TBSA). Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).

Exclusion Criteria

>24 hrs 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., Enrolment in another industry sponsored intensive care unit (ICU) intervention study., Receiving high-dose intravenous (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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In patients with severe, life-threatening burn injury, what is the effect of high dose (50 mg/kg every 6 h hrs 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?;Secondary Objective: In patients with severe, life-threatening burn injury, what is the effect of high dose (50 mg/kg every 6 hrs for 96 hours) intravenous vitamin C in addition to SOC on time to discharge alive from hospital, hospital mortality, duration of stay in intensive care unit (ICU) and hospital, and 6-month mortality, health-related quality of life, and health care resources compared to add-on placebo and SOC?;Primary end point(s): •Persistent organ dysfunction (PODS)+death at 28 days, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):•The most important secondary endpoint of this trial will be time to discharge alive from hospital.;Secondary end point(s):•The other secondary outcomes will be the components of 28-day POD which include mortality, use of inotropes or vasopressors or mechanical circulatory assistance, renal replacement therapy and mechanical ventilation and POD-free days in the first 28 days.