Study to Determine Safety and Effectiveness of Ascorbic Acid, Corticosteroids, and Thiamine in Treating Sepsis and Septic Shock

Overview

About this study

The purpose of this study is to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Adult participant (age ≥ 18 years old).
  • Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection.
  • Receiving (continous infusion) vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin):
    • Hypotension related primarily to sepsis as opposed to another cause of hypotension (e.g., bleed, cardiogenic shock).

Exclusion Criteria: 

  • Member of a protected population (pregnant, prisoner).
  • Known history of kidney stones within the past 1 year (not including incidentally noted stones noted on imaging studies).
  • End stage renal disease requiring dialysis (hemodialysis or peritoneal dialysis).
  • Known history of G6PD deficiency.
  • Known history of Hemochromatosis.
  • Comfort Measures Only status.
  • Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician).
  • Receiving supplemental vitamin 81 in a dose greater than that contained in a multivitamin (< 2mg).
  • Clinical indication for steroids (e.g., chronic use) as determined by the clinical team providing this drug.
  • Clinical indication for ascorbic acid supplementation in any form.
  • Clinical indication for vitamin 81 as determined by the clinical team providing this drug.
  • Known allergy to vitamin C, hydrocortisone, or vitamin 81.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ayan Sen, M.D.

Open for enrollment

Contact information:

Sarah Kirkland R.N.

(480)342-2479

Kirkland.Sarah@mayo.edu

More information

Publications

  • Acute kidney injury (AKI) is common in patients with sepsis and has been associated with high mortality rates. The provision of thiamine to patients with sepsis may reduce the incidence and severity of sepsis-related AKI and thereby prevent renal failure requiring renal replacement therapy (RRT). Read More on PubMed
  • The global burden of sepsis is estimated as 15 to 19 million cases annually, with a mortality rate approaching 60% in low-income countries. Read More on PubMed
  • To determine if intravenous thiamine would reduce lactate in patients with septic shock. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20445273

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