Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis
Condition: Alcoholic Hepatitis; Sepsis
MeSH terms: Hepatitis A; Sepsis; Toxemia; Hepatitis; Hepatitis, Alcoholic
Intervention: Vitamin C; Dextrose 5% in water
Intervention description: 200mg/kg/24hours; 50mL intravenously every 6 hours
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study drug will be double-blind with matching placebo. Vitamin C 200mg/kg/24hours or placebo (Dextrose 5% in water) will be given intravenously every 6 hours for up to 96 hours of treatment.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      Vitamin C (ascorbic acid) intravenous infusion when used to treat alcoholic hepatitis
      (inflammation of the liver from heavy alcohol use) and sepsis (life-threatening complication
      of an infection).
    

Eligibility criteria:

        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