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Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS)

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. Identifier: NCT03509350
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : June 12, 2019
The Marcus Foundation
Information provided by (Responsible Party):
Jonathan Sevransky, Emory University

Brief Summary:
The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable placebos for patients with sepsis. The objective of this study is to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality and improving organ function in critically ill patients with sepsis.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Vitamin C Drug: Thiamine Drug: Hydrocortisone Drug: Vitamin C Placebo Drug: Thiamine Placebo Drug: Hydrocortisone Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Adaptive Clinical Trial of Vitamin C, Thiamine and Steroids as Combination Therapy in Patients With Sepsis.
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Treatment Protocol
Participants randomized to the treatment protocol will receive the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
Drug: Vitamin C
Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Ascorbic acid

Drug: Thiamine
Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Thiamine hydrochloride

Drug: Hydrocortisone
Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Hydrocortisone sodium succinate

Placebo Comparator: Control Protocol
A placebo to match the VICTAS intervention will be administered for four days or until ICU discharge. During the treatment period, if an indication for steroids exist, the treating physicians are permitted to initiate open-label corticosteroid therapy based on local practice and international guidelines. If this occurs, the hydrocortisone/placebo will be withheld and subjects will be started on open-label corticosteroids.
Drug: Vitamin C Placebo
A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Placebo

Drug: Thiamine Placebo
A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
Other Name: Placebo

Drug: Hydrocortisone Placebo
A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.
Other Name: Placebo

Primary Outcome Measures :
  1. Vasopressor and ventilator-free days (VVFD) [ Time Frame: Day 30 ]
    The primary outcome measure is VVFD at 30 days (+/-3 days) after randomization. Vasopressor and ventilator-free days will be determined by recording all start and stop days of these measures.

Secondary Outcome Measures :
  1. Mortality at 30 days [ Time Frame: Day 30 ]
    The number of participants who did not survive until Day 30 will be compared between study arms.

  2. Delirium-free and coma-free days (DCFD) [ Time Frame: Day 14 ]
    Delirium and Coma-Free Days (DCFDs) is defined as the number of days between enrollment and day 14 the subject has a Richmond Agitation-Sedation Scale (RASS) -3 or higher and Confusion Assessment Method for the ICU (CAM-ICU) negative (or Brief Confusion Assessment Method (bCAM) negative if in the ED) among survivors at that time point (day 14). The RASS categorizes patient sedation level on a scale from -5 (unarousable sedation) to +4 (combative), where 0 indicates alert and calm. Delirium is diagnosed with the CAM when the patient exhibits an acute change in mental status and inattention plus either disorganized thinking or an altered level of consciousness.

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

Inclusion Criteria:

  • Suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent
  • Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:

    1. Vasopressor Requirement - Continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm Hg despite intravenous crystalloid infusion of at least 1000cc
    2. Respiratory Support Requirement - Acute hypoxemic respiratory failure defined as persistent hypoxemia ( partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 300 or blood oxygen saturation (SpO2)/FiO2 ≤ 315) requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask (i.e. continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or (3) high flow nasal cannula ≥ 45 liter per minute (LPM) flow and FiO2 ≥ 0.40
  • Anticipated or confirmed intensive care unit (ICU) admission

Exclusion Criteria:

  • Organ dysfunction present > 24 hours at time of enrollment
  • Limitations of care (defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria 7.1.b) including "do not intubate" (DNI) status
  • Current hospitalization > 30 days at time of randomization
  • Chronic hypoxemia requiring supplemental non-invasive oxygen (nasal cannula or NIPPV) or home mechanical ventilation
  • Chronic cardiovascular failure requiring home mechanical hemodynamic support (e.g., LVAD) or home chemical hemodynamic support (e.g., milrinone)
  • Known allergy or contraindication to vitamin C, thiamine, and/or corticosteroids (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or nown/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
  • Currently receiving intravenous vitamin C as a treatment for sepsis OR any dose of vitamin C exceeding 1 gram daily
  • Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of < 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy, neurodegenerative disease, etc.)
  • Pregnancy or known active breastfeeding
  • Prisoner or Incarceration
  • Current participation in another interventional pharmaceutical research study for sepsis
  • Inability or unwillingness of subject or legal surrogate/representative to give written informed consent

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 identifier (NCT number): NCT03509350

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Contact: Jonathan Sevransky, MD, MHS 404-778-5734

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Sponsors and Collaborators
Emory University
The Marcus Foundation
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Principal Investigator: Jonathan Sevransky, MD, MHS Emory University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jonathan Sevransky, Professor, Emory University Identifier: NCT03509350     History of Changes
Other Study ID Numbers: IRB00102528
IRB00164053 ( Other Identifier: Johns Hopkins IRB )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Sevransky, Emory University:
Vitamin C
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
Ascorbic Acid
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Inflammatory Agents
Vitamin B Complex