Vitamin C for Thermal Burns
(VICToRY Trial)
Recruiting in Palo Alto (17 mi)
+40 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Must not be taking: High-dose vitamin C, Hydroxycobalamin
Disqualifiers: Pregnancy, G6PD deficiency, Kidney stones, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this 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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving high-dose IV vitamin C or using hydroxycobalamin (vitamin B12) for suspected cyanide poisoning, you may not be eligible to participate.
What data supports the effectiveness of the drug Ascorbic Acid for treating thermal burns?
Is high-dose vitamin C safe for treating burns?
How does high-dose vitamin C treatment differ from other treatments for thermal burns?
Eligibility Criteria
Adults with severe burns covering at least 20% of their body, who need skin grafting, can join this trial. They must be able to start treatment within 24 hours of being admitted to the hospital and not already receiving high-dose IV vitamin C. Pregnant or lactating individuals, those expected not to survive the next 72 hours, with a recent history of kidney stones or certain deficiencies cannot participate.Inclusion Criteria
I am 18 years old or older.
My burns cover 20% or more of my body.
I have deep burns that need skin grafting.
Exclusion Criteria
I have been in the hospital for more than 24 hours before giving consent.
Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating
I have a G6PD deficiency.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive high-dose intravenous vitamin C or placebo for 96 hours
1 week
Daily visits for administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
28 days
Long-term follow-up
Participants' health-related quality of life and mortality are assessed
6 months
Treatment Details
Interventions
- Ascorbic Acid (Vitamin)
- placebo (Other)
Trial OverviewThe VICToRY Trial is testing if high-dose intravenous vitamin C can help critically ill burn patients recover faster and have better survival rates compared to standard care alone. Half will receive vitamin C along with standard care while the other half gets a placebo alongside standard treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin CExperimental Treatment1 Intervention
Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours
Group II: Control groupPlacebo Group1 Intervention
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Southwestern Medical Center - University of TexasDallas, TX
Centre de recherche du CHUMMontréal, Canada
Ross Tilley Burn Ctr/SunnybrookToronto, Canada
Hopital l'Enfant-JésusQuébec, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Clinical Evaluation Research Unit at Kingston General HospitalLead Sponsor
Dr. Christian Stoppe, MD, Co-Principal Investigator, Wurzburg University, Wurzburg, GermanyCollaborator
References
Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study. [2020]Vitamin C is a well-documented antioxidant that reduces oxidative stress and fluid infusion in high doses; however, the association between high-dose vitamin C and reduced mortality remains unclear. This study evaluates the effect of high-dose vitamin C in severe burn patients under two varying thresholds.
Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 3: Vitamin C in severe burns. [2018]A short-cut systematic review was carried out to establish whether high-dose vitamin C can lead to lower fluid requirements, faster recovery and lower mortality in adult patients with burns of over 15% total body surface area (TBSA). Four studies were directly relevant to the question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated. The clinical bottom line is that preliminary evidence suggests vitamin C can reduce the volume required for fluid resuscitation, improve wound healing and reduce ventilation requirements in patients with severe burns. Further evidence from large trials is required to confirm this promising early evidence.
High-dose intravenous versus low-dose oral vitamin C in burn care: potential protective effects in the severely burned: a retrospective cohort study. [2023]Antioxidant therapies, such as ascorbic acid may have an important role during the acute phase of burn management. However, there are mixed results on the most effective dose and method of administration of ascorbic acid in burn patients. In this study, we compared the efficacy of intravenously and orally administered ascorbic acid in second-degree burns greater than 20% total-body-surface-area.
Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. [2022]High-dose ascorbic acid (vitamin C) therapy (66 mg/kg per hour) attenuates postburn lipid peroxidation, resuscitation fluid volume requirements, and edema generation in severely burned patients.
Reduced resuscitation fluid volume for second-degree experimental burns with delayed initiation of vitamin C therapy (beginning 6 h after injury). [2018]We studied the hemodynamic effects of delayed initiation (6 h postburn) of antioxidant therapy with high-dose vitamin C in second-degree thermal injuries. Seventy percent body surface area burns were produced by subxiphoid immersion of 12 guinea pigs into 100 degrees C water for 3 s. The animals were resuscitated with Ringer's lactate solution (R/L) according to the Parkland formula (4 ml/kg/% burn during the first 24 h) from 6 h postburn, after which the resuscitation fluid volume was reduced to 25% of the Parkland formula volume. Animals were divided into two groups. The vitamin C group (n = 6) received R/L to which vitamin C (340 mg/kg/24 h) was added after 6 h postburn. The control group (n = 6) received R/L only. Both groups received identical resuscitation volumes. Heart rates, mean arterial blood pressure, cardiac output, hematocrit level, and water content of burned and unburned tissue were measured before injury and at intervals thereafter. No animals died. There were no significant differences in heart rates or blood pressures between the two groups throughout the 24-h study period. The vitamin C group showed significantly (P
Reduced resuscitation fluid volume for second-degree burns with delayed initiation of ascorbic acid therapy. [2019]Oxygen radicals may play an important role in injury due to thermal burns. High-dose antioxidant ascorbic acid (vitamin C, Cenolete, Abbott Laboratory, Abbott Park, Ill) therapy reduces edema of burned and unburned tissue, lipid peroxidation, and subsequent resuscitation fluid volume requirement in experimental burn models.
Metabolic and immune effects of enteral ascorbic acid after burn trauma. [2019]A burned guinea-pig model (30 per cent BSA) was used to study the effect of vitamin C on immune and metabolic responses following burn trauma. Thirty-six guinea-pigs received identical enteral diets (175 kcal/kg) except for the amount of vitamin C. Groups I, II, III and IV were given formulae delivering no vitamin C, (1 RDA) 15 mg/kg/day, 75 mg/kg/day or 375 mg/kg/day, respectively. Resistance to infection was evaluated by injecting each animal with 0.1 ml of 1 x 10(9) Staph. aureus 502A subcutaneously on day 10. On day 14, Staph. aureus abscesses were excised and the numbers of viable colonies were determined. Results showed no statistical differences between groups in the clearance of Staph. aureus. From days 2 to 12, animals in groups I, II and III had body weights of approximately 97 per cent of preburn body weight. Animals in group IV, however, had a body weight gain, 102 per cent of preburn body weight on day 12. Animals in group IV also had significantly lower metabolic rates on day 12 as compared to the animals in the other groups. These results suggest that large amounts of vitamin C have beneficial effects on the maintenance of body weight and metabolic rate following burn trauma.
Reduced fluid volume requirement for resuscitation of third-degree burns with high-dose vitamin C. [2019]The effects of high-dose vitamin C therapy (170 mg, 340 mg, and 680 mg/kg/day) were evaluated in 70% body surface area third-degree burns in guinea pigs that were resuscitated with 1 ml/kg/%burn Ringer's lactate solution. The water content measurements of the burned skin at 24 hours after burn injury in the vitamin C-treated groups were significantly lower than those of the control group (1 ml/kg/%burn) and those of the standard resuscitation group (4 ml/kg/%burn). The cardiac outputs in the group that received 340 mg vitamin C were significantly higher than those of the control group but not significantly different than those of the standard therapy group at 2 hours after burn injury and thereafter. In comparison with the regimen of 340 mg vitamin C, the regimen of 680 mg vitamin C was no more beneficial, and the regimen of 170 mg was less effective. With administration of adjuvant high-dose vitamin C, we were able to reduce the total 24-hour resuscitation volume from 4 ml/kg/%burn to 1 ml/kg/%burn, while a comparable cardiac output was maintained.