Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Model for End Stage Liver Disease (MELD) Score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vitamin C infusion (ascorbic acid)
Vitamin C 200mg/kg/24hours administered in four doses per day (given every 6 hours)
干预措施: Vitamin C (Drug)
Vitamin C infusion (ascorbic acid)
Vitamin C 200mg/kg/24hours administered in four doses per day (given every 6 hours)
干预措施: Dextrose 5% in water (Drug)
Placebo
Dextrose 5% in water 50 milliliters (mL) administered intravenously every 6 hours
干预措施: Dextrose 5% in water (Drug)
结局指标
主要结局
Change in Model for End Stage Liver Disease (MELD) Score
时间窗: Baseline and 96 hours
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).
次要结局
- 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 Albumin(Baseline and 96 hours)
- Change in Total Bilirubin(Baseline and 96 hours)
- Number of Treatment-related Adverse Events as Assessed by CTCAE v5.0(up to 96 hours)
- ICU-free Days(Day 28)
- Change in Alanine Aminotransferase (ALT) Level(Baseline and 96 hours)
- Change in Alkaline Phosphatase(Baseline and 96 hours)
- Changes to Corrected QT Interval (QTc)(Baseline and 96 hours)
- Changes to Urine pH(Baseline and 96 hours)
- Changes to Urine Microscopy(Baseline and 96 hours)
- Hospital-free Days(Day 90)
- Changes to Level of Medical Care(up to 168 hours)
- Number of Deaths Due to Any Cause(Day 90)