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 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rosen Mann
408-460-5885
Recruiting