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



Status:Recruiting
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:February 9, 2018
End Date:September 30, 2019
Contact:Michael W. Donnino, MD
Email:mdonnino@bidmc.harvard.edu
Phone:617-754-2341

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Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial

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.

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) demonstrated a remarkable benefit when the combination of Ascorbic Acid (Vitamin
C), Corticosteroids, and Thiamine (Vitamin B1) were given to patients with sepsis. In
particular, patients who received this combination of medications required a shorter amount
of time on vasopressors, suffered less organ failure, and had improved mortality. Vitamin C
has long been suggested for treatment of patients with severe infection as it exerts
significant anti-oxidant effects and reduces endothelial permeability. Corticosteroids, a
mainstay of therapy for refractory shock in sepsis, have also been shown to enhance the
beneficial cellular effects of vitamin C. Finally, thiamine has been shown to be an effective
mitochondrial resuscitator in sepsis, especially for the ~30% of septic shock patients who
present with thiamine deficiency (Donnino et. al, PMID 26771781).

In this study, we aim to reproduce the findings of Marik et. al. using a more rigorous study
design (i.e. a blinded, randomized clinical trial) and focus on the important clinical
outcomes of organ failure and death.

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

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. Known allergy to vitamin C, hydrocortisone, or thiamine
We found this trial at
13
sites
Phoenix, Arizona 85054
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Michael W Donnino, MD
Phone: 617-754-3464
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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6071 West Outer Drive
Detroit, Michigan 48235
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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Cambridge, Massachusetts 02144
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Detroit, Michigan 48202
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Detroit, Michigan 48201
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Houston, TX
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270-05 76th Avenue
New York, New York 11040
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Royal Oak, Michigan 48073
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Royal Oak, MI
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