Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Rate of bacterial infections
研究概览
简要总结
Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.
The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.
详细描述
Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.
Endpoints:
- Primary endpoint: Bacterial infections after 90 days.
- Secondary endpoints: :
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 and <70 years of age.
- •Active alcohol abuse and excessive alcohol consumption prior to admission defined as > 50 g per day for men and> 40 g per day for women.
- •Jaundice (Bilirubin >2 mg/dl) for no more than 3 months.
- •Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function > 32 points.
排除标准
- •Hypersensitivity to Rifaximin
- •Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA> II, COPD PCO2> 50 mmHg or PO2 <60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).
- •Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months
- •Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.
- •Complete portal vein thrombosis (previously diagnosed).
- •Autoimmune liver disease.
- •Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive).
- •Pregnancy or nursing.
- •Use of Rifaximin during the previous 2 months.
- •Treatment with Pentoxifylline.
- •Lack of informed consent.
- •Removal criteria:
- •Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion.
- •Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:
- •Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).
- •Inflammatory infiltrate (predominantly polymorphonuclear cells). Pericellular or sinusoidal fibrosis.
- •Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 days after inclusion.
- •Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.
- •Protocol violation.
- •Severe adverse event directly related with Rifaximin.
研究组 & 干预措施
Prednisone
Prednisone PO 40mg/day for 30 days plus standard supportive care measurements
干预措施: Prednisone (Drug)
Prednisone plus Rifaximin
Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements
干预措施: Prednisone (Drug)
Prednisone plus Rifaximin
Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements
干预措施: Rifaximin (Drug)
结局指标
主要结局
Rate of bacterial infections
时间窗: 90 days
Development of any bacterial infection.
次要结局
- Rate of Decompensations of Liver Cirrhosis(90 days)