Trial Search Results

Vitamin C, Thiamine, and Steroids in Sepsis

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Emory University

Collaborator: The Marcus Foundation

Stanford Investigator(s):

Intervention(s):

  • Drug: Vitamin C
  • Drug: Thiamine
  • Drug: Hydrocortisone
  • Drug: Vitamin C Placebo
  • Drug: Thiamine Placebo
  • Drug: Hydrocortisone Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Suspected or confirmed infection as evidenced by ordering of blood cultures and
   administration of at least one antimicrobial agent

   - Anticipated or confirmed intensive care unit (ICU) admission

   - 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
      ≥ 40 liter per minute (LPM) flow and FiO2 ≥ 0.40

Exclusion Criteria:

   - Weight < 40 kilograms (kg)

   - Prior enrollment in this study

   - Qualifying organ dysfunction no longer present at the time subject would be randomized

   - Cardiovascular or respiratory organ failure caused by an illness other than sepsis

   - First episode of qualifying organ dysfunction during the current emergency department
   (ED) or ICU admission occurred > 24 hours before the subject could be randomized

   - Limitations of care (defined as refusal of cardiovascular and respiratory support
   modes) 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 known/suspected ethylene glycol ingestion, or known
   glucose-6-phosphate dehydrogenase (G6PD) deficiency)

   - Use of vitamin C at a dose of > 1 gram daily within the 24 hours preceding first
   episode of qualifying organ dysfunction during a given ED or ICU admission

   - 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 research study

   - Inability or unwillingness of subject or legal surrogate/representative to give
   written informed consent

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann
408-460-5885
Not Recruiting