A Phase 3 interventional study of Ascorbic Acid and placebo in Shock and Thermal Burn, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital. Suspended at 33 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Clinical Evaluation Research Unit at Kingston General Hospital · Phase 3, Interventional, and Treatment
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.
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 (50mg/kg every 6 hours 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.
Patients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg 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.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 666 is above the median of 100 across 229 interventional studies indexed under Shock.
Browse Shock studies →Clinical Evaluation Research Unit at Kingston General Hospital is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours
Drug: Ascorbic Acid
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 intravenous vitamin C (50 mg/kg every 6 hours for 96 hours).
Also known as: vitamin C
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
Also known as: saline, D5W
Persistent Organ Dysfunction + Death
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 frame: at 28 days
Time to discharge alive from hospital
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.
Time frame: 90 days
Components of PODS+28-day mortality
Mortality at 28 days / Use of inotropes or vasopressors at 28 days / Renal replacement therapy at 28 days / On mechanical ventilation at 28 days.
Time frame: 28 days
POD (persistent organ dysfunction)-free days
All days free from persistent organ dysfunction within the first 28 days after admission
Time frame: 28 days
ICU length of stay
Duration of time in the ICU
Time frame: 90 days
Duration of mechanical ventilation
Length of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.
Time frame: 90 days
ICU readmission rate
Incidents of readmission to ICU from within the hospital
Time frame: 90 days
Hospital mortality
Did the patient die in hospital or was the patient discharged?
Time frame: 90 days
Hospital length of stay
Duration of time in the hospital
Time frame: 90 days
Gram negative bacteremia
Venous or arterial blood cultures that show bacteremia with Gram-negative bacilli
Time frame: 90 days
6 month mortality
Is the patient alive or deceased 6 months post admission.
Time frame: 6 months
Health-related quality of life
Administration of the SF-36 questionnaire 6 months post admission
Time frame: 6 months
Health related quality of life
Administration of the Katz-ADL (activities of daily living) questionnaire 6 months post admission. This assessment is scored from 0 - 6 with a higher score indicating better functioning.
Time frame: 6 months
Health related quality of life
Administration of the Lawton-IADL (Instrumental Activities of Daily Living) questionnaire 6 months post admission. This assessment is scored from 0 - 8 with a higher score indicating better functioning.
Time frame: 6 months
Burn related procedures
Frequency of operative procedures for burn care.
Time frame: 90
Blood products given
Type and volume of blood products given.
Time frame: 8 days
Inhalation injury
The presence or absence of smoke inhalation injury and whether confirmed by bronchoscopy.
Time frame: 24 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2020 to primary completion in Dec 2025, 64 months.
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This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ascorbic Acid
Clinical Evaluation Research Unit at Kingston General Hospital