Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Sepsis, Septic Shock, Metabolic Disturbance

In brief

In this study, we aim 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.

Key facts

Study ID

NCT03389555

Run by

Beth Israel Deaconess Medical Center

People needed

205

Starts

2018-02-09

Expected to finish

2020-02-28

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient (age ≥ 18 years)
• Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection
• Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

You may not qualify if…

• Member of a protected population (pregnant, prisoner)
• Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)
• End stage renal disease (ESRD) requiring dialysis
• Known Glucose-6-Phosphate Dehydrogenase deficiency
• Known Hemachromatosis
• Comfort Measures Only status
• Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)
• Receiving supplemental thiamine in a dose greater than that contained in a multivitamin
• Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug
• Clinical indication for thiamine as determined by the clinical team providing this drug
• Clinical indication for ascorbic acid as determined by the clinical team providing this drug
• Known allergy to vitamin C, hydrocortisone, or thiamine

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• North Shore University Hospital — Manhasset, New York, United States
• Long Island Jewish Hospital — New York, New York, United States
• University Of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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