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Trial record 8 of 27 for:    Heyland

VItamin C in Thermal injuRY: The VICToRY Pilot Trial (VICToRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138394
Recruitment Status : Not yet recruiting
First Posted : October 24, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Shock Thermal Burn Drug: Ascorbic Acid Drug: placebo Phase 2

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 (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Vitamin C
Patients will receive intravenous vitamin C at 200mg/kg in divided doses, every 6 hrs for 96 hrs.
Drug: Ascorbic Acid
We will conduct a double-blind, randomized controlled pilot trial of 90 patients with severe burns randomly allocated to receive intravenous vitamin C (200 mg/kg/day for 96 hours) or placebo (45 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

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.
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:
  • saline
  • D5W




Primary Outcome Measures :
  1. 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.

  2. Oxidation-reduction potential (ORP) [ Time Frame: 96 hours ]
    Oxidation-reduction potential (ORP), or redox-status measured at 96 hrs (end of treatment period).


Secondary Outcome Measures :
  1. 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)

  2. 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.


Other Outcome Measures:
  1. ICU length of stay [ Time Frame: 90 days ]
    Duration of time in the ICU

  2. Duration of mechanical ventilation [ Time Frame: 90 days ]
    Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.

  3. ICU readmission rate [ Time Frame: 90 days ]
    Incidents of readmission to ICU from within the hospital

  4. Hospital mortality [ Time Frame: 90 days ]
    Did the patient die in hospital or was the patient discharged?

  5. Hospital length of stay [ Time Frame: 90 days ]
    Duration of time in the hospital

  6. Wound healing [ Time Frame: 90 days ]
    time-to-95% graft closure

  7. Gram negative bacteremia [ Time Frame: 90 days ]
    Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli

  8. 6 month mortality [ Time Frame: 6 months ]
    Is the patient alive or deceased 6 months post admission.

  9. Health-related quality of life [ Time Frame: 6 months ]
    Administration of the SF-36 questionnaire 6 months post admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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).

Information from the National Library of Medicine

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


Contacts
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Contact: Maureen Dansereau 613-549-6666 ext 6686 maureen.dansereau@kingstonhsc.ca

Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
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Principal Investigator: Daren K Heyland, MD Queen's University
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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: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents