Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

HM20014364

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).

2019-04-16

2022-03-31

2022-06-23

Completed

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-08-28