Status:
COMPLETED
Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholic Hepatitis
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- Alcoholic Hepatitis diagnosed by one of the following methods:
- liver biopsy
- 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)
- Suspected or proven infection
- 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).
- Presence of organ failure due to the body's response to infection indicated by any of the following:
- Hypotension (low blood pressure) or need for medications to raise blood pressure
- Arterial hypoxemia (low blood oxygen) or need for high flow of oxygen
- High lactate level (blood test indicating active response to infection)
- Low urine output despite administration of intravenous fluids
- Low platelet count (blood test)
- Coagulopathy (decreased blood clotting ability based on a blood test)
- High bilirubin (blood test)
- Mental status changes (confusion or delirium)
- Absence of drugs present on urine or blood tests that indicate the possibility of liver damage or mental status changes from other causes
Exclusion
- Allergy to Vitamin C
- Unable to provide consent
- Age less than 18 years
- No intravenous access (IV line) in a patient needing glucose (blood sugar) checks more than twice daily
- Presence of diabetic ketoacidosis (a serious complication of diabetes)
- Inability of patient, legally authorized representative and/or physician to commit to full medical support
- Pregnancy or breast feeding
- Life expectancy less than 24 hours
- Active or history of kidney stone
- History of chronic kidney disease
- History of glucose-6-phosphate deficiency (a low blood protein that can cause red blood cells to break down)
- Active cancer (except non-melanoma skin cancer)
- Uncontrolled gastrointestinal bleeding
- Other causes of liver injury such as viruses, autoimmune disease, drug toxicity
- 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)
- History of organ transplantation
- Initial AST or ALT (blood test indicating a liver problem)
- Presence of acetaminophen or other drugs on urine or blood toxicology test
- Non-English speaking
- Prisoner or other ward of the state
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03829683
Start Date
April 16 2019
End Date
June 23 2022
Last Update
August 28 2023
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298