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Phase 2 N=20 Randomized Quadruple-blind Treatment

Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

Alcoholic Hepatitis · Sepsis

Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Model for End Stage Liver Disease (MELD) Score — -0.13; -2.9; -2.3; -2.4 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Vitamin C (Drug); Dextrose 5% in water (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Virginia Commonwealth University
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Model for End Stage Liver Disease (MELD) Score
-0.13; -2.9; -2.3; -2.4
SECONDARY
Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score
14; 15.33; 12.75
SECONDARY
Change in Aspartate Aminotransferase (AST) Level
176.0; -16.5
SECONDARY
Change in Alanine Aminotransferase (ALT) Level
62.71; 1.00
SECONDARY
Change in Total Bilirubin
-0.30; 0.45
SECONDARY
Change in Alkaline Phosphatase
-5.71; -7.50
SECONDARY
Change in Albumin
-0.10; 0.06
SECONDARY
Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0
12; 11
SECONDARY
Changes to Corrected QT Interval (QTc)
-10.00; -58.17
SECONDARY
Changes to Urine pH
5.31; 5.17
SECONDARY
Changes to Urine Microscopy
0; 0; 0; 0
SECONDARY
Changes to Level of Medical Care
2; 1
SECONDARY
ICU-free Days
16.40; 13.20
SECONDARY
Number of Deaths Due to Any Cause
5; 4
SECONDARY
Number of Deaths Due to Any Cause
5; 4
SECONDARY
Hospital-free Days
58.40; 48.88

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

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03829683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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