Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

Alcoholic hepatitis is inflammation of the liver due to alcohol consumption. It can cause one
or more of the following symptoms such as jaundice (yellow discoloration of the eyes and
skin), pain on the right side of the abdomen, and is accompanied by an enlarged liver. Sepsis
is a life-threatening complication of an infection. As the body tries to fight an infection
it sends chemicals into the bloodstream. These chemicals that are trying to fight the
infection can cause inflammation. This inflammation can cause damage to many body systems and
make them fail. Patients with alcoholic hepatitis and sepsis have low levels of Vitamin C in
the bloodstream. Vitamin C has been shown to reduce inflammation and organ dysfunction in
patients with severe infections.

The investigators do not yet know if Vitamin C will be effective in alcoholic hepatitis.
Taking Vitamin C by mouth is not effective as a treatment in people with this condition so
participants will receive the Vitamin C intravenously (IV). Participants will be randomly
assigned to receive either Vitamin C or a placebo given through an IV every six hours for
four days.

Inclusion Criteria:

1. Alcoholic Hepatitis diagnosed by one of the following methods:

1. liver biopsy

2. clinical diagnosis based on history of alcohol use, presence of jaundice
(yellowing of skin), blood tests indicating liver injury, and absence of other
causes of liver injury (autoimmune disease, viral hepatitis, drug toxicity)

2. Suspected or proven infection

3. Presence of systemic inflammatory response to infection (fever, hypothermia (low
temperature), tachycardia (fast heart rate), leukocytosis (high white blood cell
count), leukopenia (low white blood cell count), high respiratory (breathing) rate, or
need for mechanical ventilation (a machine to assist in breathing).

4. Presence of organ failure due to the body's response to infection indicated by any of
the following:

1. Hypotension (low blood pressure) or need for medications to raise blood pressure

2. Arterial hypoxemia (low blood oxygen) or need for high flow of oxygen

3. High lactate level (blood test indicating active response to infection)

4. Low urine output despite administration of intravenous fluids

5. Low platelet count (blood test)

6. Coagulopathy (decreased blood clotting ability based on a blood test)

7. High bilirubin (blood test)

8. Mental status changes (confusion or delirium)

5. Absence of drugs present on urine or blood tests that indicate the possibility of
liver damage or mental status changes from other causes

Exclusion Criteria:

1. Allergy to Vitamin C

2. Unable to provide consent

3. Age less than 18 years

4. No intravenous access (IV line) in a patient needing glucose (blood sugar) checks more
than twice daily

5. Presence of diabetic ketoacidosis (a serious complication of diabetes)

6. Inability of patient, legally authorized representative and/or physician to commit to
full medical support

7. Pregnancy or breast feeding

8. Life expectancy less than 24 hours

9. Active or history of kidney stone

10. History of chronic kidney disease

11. History of glucose-6-phosphate deficiency (a low blood protein that can cause red
blood cells to break down)

12. Active cancer (except non-melanoma skin cancer)

13. Uncontrolled gastrointestinal bleeding

14. Other causes of liver injury such as viruses, autoimmune disease, drug toxicity

15. History of severe liver cirrhosis complications including variceal bleeding within the
last 3 months, large ascites (fluid accumulation in the abdomen) or hepatocellular
carcinoma (liver cancer)

16. History of organ transplantation

17. Initial AST or ALT (blood test indicating a liver problem)

18. Presence of acetaminophen or other drugs on urine or blood toxicology test

19. Non-English speaking

20. Prisoner or other ward of the state