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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
200mg/kg/24hours
50mL intravenously every 6 hours
Virginia Commonwealth University
Richmond, Virginia, United States
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).
Time frame: Baseline and 96 hours
Change in Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA) Score
A number that ranges from 0 (least sick) to 24 (most sick) and ranks the degree of sickness from liver failure and several other organ systems in a critically ill person. The score is determined by evaluating a person's liver function, kidney function, nervous system (brain), coagulation (blood clotting), circulation (blood pressure), and respiratory status (breathing)
Time frame: Baseline and 96 hours
Change in Aspartate Aminotransferase (AST) Level
Standard blood test used to determine the severity and nature of liver problems.
Time frame: Baseline and 96 hours
Change in Alanine Aminotransferase (ALT) Level
Standard blood test used to determine the severity and nature of liver problems.
Time frame: Baseline and 96 hours
Change in Total Bilirubin
Standard blood test used to determine the severity and nature of liver problems.
Time frame: Baseline and 96 hours
Change in Alkaline Phosphatase
Standard blood test used to determine the severity and nature of liver problems.
Time frame: Baseline and 96 hours
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Change in Albumin
Standard blood test used to determine the severity and nature of liver problems.
Time frame: Baseline and 96 hours
Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Observation about the need to change the dose of study medication and symptoms such as headache, dizziness, dry mouth, nausea, vomiting, flushing, rash, or hypotension (low blood pressure)
Time frame: up to 96 hours
Changes to Corrected QT Interval (QTc)
An electrocardiogram (ECG or test of the electrical activity of the heart) is performed to determine if there are changes to the heart rhythm.
Time frame: Baseline and 96 hours
Changes to Urine pH
Urine samples are collected to determine changes in pH (acidity) that could indicate a risk for kidney stones. The pH scale ranges from 0 to 14, with smaller numbers meaning more acidic and higher numbers meaning more basic. A pH of 7 is considered to be neutral. Normal levels of urine pH range from 4.6 - 8 on the pH scale.
Time frame: Baseline and 96 hours
Changes to Urine Microscopy
Urine samples are collected to check for the presence of crystalluria (microscopic crystals) that could indicate a risk for kidney stones.
Time frame: Baseline and 96 hours
Changes to Level of Medical Care
Documentation of the need for more intensive medical care such as ventilator (breathing machine) or vasopressors (intravenous medications use increase blood pressure) when not needed at baseline
Time frame: up to 168 hours
ICU-free Days
The number of days not spent in an intensive care unit (ICU)
Time frame: Day 28
Number of Deaths Due to Any Cause
Any cause of death that is anticipated or unanticipated
Time frame: Day 28
Number of Deaths Due to Any Cause
Any cause of death that is anticipated or unanticipated
Time frame: Day 90
Hospital-free Days
The number of days spent outside of the hospital
Time frame: Day 90