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. 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:

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Ayan Sen, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ayan Sen, M.D.

Closed for enrollment

More information

Publications

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
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
To determine if intravenous thiamine would reduce lactate in patients with septic shock. Read More on PubMed

Clinical Trials