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

• Status: Completed
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Open Philanthropy Project
• Treatments: Ascorbic Acid; Hydrocortisone; Thiamine; Vitamins

Criteria

Inclusion Criteria:

1. Adult patient (age ≥ 18 years)

2. Suspected (cultures drawn and antibiotic given) or confirmed (via culture results) infection

3. Receiving vasopressor (norepinephrine, phenylephrine, epinephrine, dopamine, angiotensin II or vasopressin)

Exclusion Criteria:

1. Member of a protected population (pregnant, prisoner)

2. Known kidney stones within the past 1 year (except for asymptomatic, incidentally noted stones on imaging)

3. End stage renal disease (ESRD) requiring dialysis

4. Known Glucose-6-Phosphate Dehydrogenase deficiency

5. Known Hemachromatosis

6. Comfort Measures Only status

7. Anticipated death within 24-hours despite maximal therapy (as determined by the enrolling physician)

8. Receiving supplemental thiamine in a dose greater than that contained in a multivitamin

9. Clinical indication for steroids (e.g. chronic use) as determined by the clinical team providing this drug

10. Clinical indication for thiamine as determined by the clinical team providing this drug

11. Clinical indication for ascorbic acid as determined by the clinical team providing this drug

12. Known allergy to vitamin C, hydrocortisone, or thiamine