Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Germans Trias i Pujol Hospital | OTHER |
| Hospital del Mar | OTHER |
| Hospital de Sant Pau | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Prednisone PO 40mg/day for 30 days plus standard supportive care measurements |
|
| Prednisone plus Rifaximin | Experimental | Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of bacterial infections | Development of any bacterial infection. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Decompensations of Liver Cirrhosis | Development of any liver cirrhosis decompensations
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Endotoxemia serum levels | Measurement of serum changes in endotoxemia levels during the rifaximin treatment. | 90 days |
Inclusion Criteria:
Exclusion Criteria:
Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months
Removal criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Victor Vargas, MD | Internal Medicine Service. Vall d'Hebron Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||||
| Hospital del Mar |
Not provided
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D001424 | Bacterial Infections |
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
Not provided
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifaximin | Drug | Rifaximin PO 1200 mg/day for 90 days |
|
| Barcelona |
| Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | Spain |
| Vall d'Hebron Hospital | Barcelona | Spain |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |