Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

NCT ID: NCT03829683

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2022-06-23

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 liver from heavy alcohol use) and sepsis (life-threatening complication of an infection).

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 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.

Conditions

Alcoholic Hepatitis; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin C infusion (ascorbic acid)

Vitamin C 200mg/kg/24hours administered in four doses per day (given every 6 hours)

Group Type: ACTIVE_COMPARATOR

Vitamin C

Intervention Type: DRUG

200mg/kg/24hours

Dextrose 5% in water

Intervention Type: DRUG

50mL intravenously every 6 hours

Placebo

Dextrose 5% in water 50 milliliters (mL) administered intravenously every 6 hours

Group Type: PLACEBO_COMPARATOR

Dextrose 5% in water

Intervention Type: DRUG

50mL intravenously every 6 hours

Interventions

Vitamin C

200mg/kg/24hours

Intervention Type: DRUG

Dextrose 5% in water

50mL intravenously every 6 hours

Intervention Type: DRUG

Other Intervention Names

ascorbic acid; AscA; Ascor; D5W

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arun J Sanyal, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AA026966

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20014364

Identifier Type: -

Identifier Source: org_study_id