Status:
COMPLETED
Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Open Philanthropy
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 pa...
Detailed Description
Sepsis and Septic Shock are common and highly morbid clinical conditions without any specific therapy aside from antibiotics. A recent quasi-experimental study (Marik et. al., PMID 27940189) demonstra...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03389555
Start Date
February 9 2018
End Date
February 28 2020
Last Update
February 16 2021
Active Locations (13)
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1
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Mount Auburn Hospital
Cambridge, Massachusetts, United States, 02138