VItamin C in Thermal injuRY: The VICToRY Pilot Trial (VICToRY)
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| ClinicalTrials.gov Identifier: NCT04138394 |
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Recruitment Status :
Recruiting
First Posted : October 24, 2019
Last Update Posted : August 23, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Shock Thermal Burn | Drug: Ascorbic Acid Drug: placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Patients will be allocated to receive intravenous vitamin C at 200mg/kg in divided doses, every 6 hrs for 96 hrs. 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Allocation will be random and concealed and will be blinded to everyone except the pharmacist at each site. The vitamin C will be sourced locally and prepared in a blinded manner by local research pharmacies that will be responsible for preparing study samples and delivering them to the ICU in a blinded fashion. The randomization system, which has proven reliable in several prior RCTs, has a robust audit trail, and will maintain concealment and blinding. |
| Primary Purpose: | Treatment |
| Official Title: | VItamin C in Thermal injuRY: The VICToRY Pilot Trial A Feasibility Study for a Seamless Adaptive Phase II/II Multi-center Randomized Trial |
| Actual Study Start Date : | July 24, 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin C
Patients will receive intravenous vitamin C at 200mg/kg in divided doses, every 6 hrs for 96 hrs.
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Drug: Ascorbic Acid
We will conduct a double-blind, randomized controlled pilot trial of 180 patients with severe burns randomly allocated to receive intravenous vitamin C (200 mg/kg/day for 96 hours) or placebo (90 per group). If feasibility is demonstrated in the pilot, a larger phase III component will be conducted and aimed at lowering morbidity and mortality and reducing health care costs in an otherwise very devastating and disabling injury worldwide.
Other Name: vitamin C |
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Placebo Comparator: Control group
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
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Drug: placebo
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
Other Names:
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- Feasibility of conducting the protocol [ Time Frame: 6 months ]Evaluation of feasibility metrics to determine compliance with the study protocol, lost to follow-up and consent failure rates, and enrollment rates to assess the feasibility of conducting the study.
- Oxidation-reduction potential (ORP) [ Time Frame: 96 hours ]Oxidation-reduction potential (ORP), or redox-status measured at 96 hrs (end of treatment period).
- PODS+death [ Time Frame: 90 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)
- Time to Discharge Alive [ Time Frame: 90 days ]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.
- ICU length of stay [ Time Frame: 90 days ]Duration of time in the ICU
- Duration of mechanical ventilation [ Time Frame: 90 days ]Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.
- ICU readmission rate [ Time Frame: 90 days ]Incidents of readmission to ICU from within the hospital
- Hospital mortality [ Time Frame: 90 days ]Did the patient die in hospital or was the patient discharged?
- Hospital length of stay [ Time Frame: 90 days ]Duration of time in the hospital
- Wound healing [ Time Frame: 90 days ]time-to-95% graft closure
- Gram negative bacteremia [ Time Frame: 90 days ]Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli
- 6 month mortality [ Time Frame: 6 months ]Is the patient alive or deceased 6 months post admission.
- Health-related quality of life [ Time Frame: 6 months ]Administration of the SF-36 questionnaire 6 months post admission
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138394
| Contact: Maureen Dansereau | 613-888-4320 | maureen.dansereau@queensu.ca |
Show 25 study locations
| Principal Investigator: | Daren K Heyland, MD | Queen's University |
Documents provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:
| Responsible Party: | Daren K. Heyland, Dr. Daren Heyland, MD, MSc, FRCPC, Clinical Evaluation Research Unit at Kingston General Hospital |
| ClinicalTrials.gov Identifier: | NCT04138394 |
| Other Study ID Numbers: |
VICToRY |
| First Posted: | October 24, 2019 Key Record Dates |
| Last Update Posted: | August 23, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ascorbic Acid Vitamins Micronutrients Physiological Effects of Drugs |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |