VItamin C in Thermal injuRY: The VICToRY Pilot Trial

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    90
  • sponsor
    Clinical Evaluation Research Unit at Kingston General Hospital
Updated on 28 February 2021
critical illness

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 (200mg/kg/day x 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 200mg/kg in divided doses, 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.

Details
Condition Shock, Thermal Burns, Thermal Burn, collapse, circulatory failure, circulatory collapse
Treatment Placebo, Ascorbic acid
Clinical Study IdentifierNCT04138394
SponsorClinical Evaluation Research Unit at Kingston General Hospital
Last Modified on28 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Shock or Thermal Burn?
Do you have any of these conditions: Thermal Burn or Thermal Burns or circulatory failure or collapse or circulatory collapse or Shock?
Do you have any of these conditions: Thermal Burn or Shock or circulatory failure or circulatory collapse or collapse or Thermal Burns?
years of age or older
Deep 2nd and/or 3rd degree burns requiring skin grafting
Minimum burn size of =>25% Total Body Surface Area (TBSA)

Exclusion Criteria

>24 hours from admission to ICU or burn unit to assessment
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 (co-enrollment in the RE-ENERGIZE trial is allowed)
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)
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