A Study to Evaluate the Effectiveness of Vitamin C, Thiamine, and Steroids as Continuation Therapy in Treating Patients with Sepsis

Overview

About this study

The purpose of this study is to investigate the effectiveness 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 effectiveness of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality and improving organ function in critically ill patients with sepsis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Age > 18  years old.
  • 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 and/or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:
    • Respiratory Support Requirement – Acute hypoxemic respiratory failure defined as persistent hypoxemia (PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 315) requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask (i.e. CPAP or BIPAP) or (3) high flow nasal cannula ≥ 40 LPM flow and FiO2 ≥ 0.40
  • 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.

Exclusion Criteria:

  • Age < 18 years of age.
  • Weight < 40 kg.
  • Prior enrollment in VICTAS.
  • Qualifying organ dysfunction no longer present at the time subject would be randomized (does not require either (1) respiratory support as defined above to maintain PaO2/FiO2 > 300 or SpO2/FiO2 > 315 or (2) vasopressor infusion to maintain a mean arterial pressure ≥ 65 mm Hg).
  • Cardiovascular or respiratory organ failure caused by an illness other than sepsis.
  • First episode of qualifying organ dysfunction during the current ED or ICU admission occurred > 24 hours before subject could be randomized (patients may be reconsidered for enrollment during a subsequent ED or ICU admission)
  • 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 known contraindication to vitamin C, thiamine, or corticosteroids (including previous history or active diagnosis of primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known G6PD Deficiency).
  • Use of vitamin C at a dose of > 1g/day (IV or oral) 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.
    • *Note: Co-enrollment in other interventional research studies requires written permission from the VICTAS Executive Committee in advance of subject identification.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Casey Clements, M.D., Ph.D.

Open for enrollment

Contact information:

Joel Anderson

(507)255-9098

Anderson.Joel@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20446939

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