Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

NCT03829683 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HM20014364U01AA026966
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcoholic Hepatitis; Sepsis

Outcome Measures

Primary Outcomes (1)

• Change in Model for End Stage Liver Disease (MELD) Score

  Change in MELD score from Day 0 to Day 4. MELD score ranges from 6 (least sick) to 40 (most sick) based on blood tests which ranks the degree of sickness from liver disease. The lab tests used to determine the MELD score are creatinine, bilirubin, and international normalized ratio (INR).

  Baseline and 96 hours

Secondary Outcomes (15)

• Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score

  Baseline and 96 hours

• Change in Aspartate Aminotransferase (AST) Level

  Baseline and 96 hours

• Change in Alanine Aminotransferase (ALT) Level

  Baseline and 96 hours

• Change in Total Bilirubin

  Baseline and 96 hours

• Change in Alkaline Phosphatase

  Baseline and 96 hours

Study Arms (2)

Vitamin C infusion (ascorbic acid)

ACTIVE COMPARATOR

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

Drug: Vitamin C; Drug: Dextrose 5% in water

Placebo

PLACEBO COMPARATOR

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

Drug: Dextrose 5% in water

Interventions

Vitamin C DRUG

200mg/kg/24hours

Also known as: ascorbic acid, AscA, Ascor

Vitamin C infusion (ascorbic acid)

Dextrose 5% in water DRUG

50mL intravenously every 6 hours

Also known as: D5W

Placebo; Vitamin C infusion (ascorbic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic; Sepsis

Interventions

Ascorbic Acid; Glucose; Water

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Hexoses; Monosaccharides; Sugars; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Arun J Sanyal, MD
• Organization: Virginia Commonwealth University

arun.sanyal@vcuhealth.org

804-828-4060

Study Officials

• Arun J Sanyal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 4, 2019
• Study Start: April 16, 2019
• Primary Completion: March 31, 2022
• Study Completion: June 23, 2022
• Last Updated: August 28, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)