Clinical trial NCT04142723: Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
Official title: Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis, Alcoholic
Keywords: alcoholic, liver disease, cirrhosis
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: ALEH
name: Hospital Nacional Hipolito
name: Hospital Goyoneche Arequipa
name: Hospital Nacional Edgardo Rebagliati Martins
name: HBCASE
name: Hospital Regional Honorio Delgado Arequipa Peru
name: Hospital Nacional Daniel Alcides Carrión - Callao
name: Instituto de Gastroenterología
name: Hospital Docente Clinico Quirurgico:Manuel Piti Fajardo
name: Hospital de Clínicas D. N. Avellaneda
name: Hospital Padilla. Tucuman
name: Hospital Pablo Soria. Jujuy
name: FUNDACIÓN SAYANI
name: Hospital Italiano Buenos Aires
name: Rosario
name: Hospital de Gastroenterología Dr Carlos Bonorino Udaondo
name: Hospital Austral de Buenos Aires
name: Francisco Alfonso Solís Galindo
name: Centro de Investigación en Enfermedades Hepáticas y Gastroenterología
name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Hospital General de Mexico
name: Hospital Eugenio Espejo
name: Hospital de Especialidades de las FF.AA Quito
name: Hospital Carlos Andrade Marín
name: Hospital General San Juan de Dios
name: Hospital Roosevelt
name: Hospital San Vicente Fundación Medellín
name: Clinica Universitaria Colombia
name: Hospital San Vicente Fundación - Rionegro
name: Fundacion Cardioinfantil
name: Hospital Pablo Tobon Uribe. Univ. De Antioquia
name: Fundação Hospital Adriano Jorge
name: Hospital do Rocio
name: Hospital das Clinacas Riberao Preto
name: Universidade Estadual Paulista (UNESP) - Botucatu/São Paulo
name: FUNDHACRE- Serviço de Assistência Especializada- Acre
name: Hospital Getúlio Vargas - Teresina/Piauí
name: Hospital do Servidor Público Estadual - São Paulo/São Paulo
name: Hospital Federal de Bonsucesso - Rio de Janeiro/Rio de Janeiro
name: CHP/ Cl Davila / HCUH
name: Hospital San Juan de Dios
name: Hospital Sotero Del Rio
name: Hospital San Borja-Arriaran
name: University of Chile
name: Hospital Clinico Universidad Catolica
name: Hospital de Concepcion
name: Hospital Escuela
First posted: 2019-10-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consumption of more than 3 drinks per day in women and more than 4 drinks per day in men

Brief summary: The primary objective of this study is to determine the prevalence of AH in addition to its clinical characteristics and in-hospital mortality of patients that are hospitalized for AH in different hospitals across Latin American countries This study is carried out in different health centers throughout America, with all the countries belonging to the Latin American Association for the study of liver diseases (ALEH) more Canada and United States This would allow us to better understand the epidemiology of AH in our region and thus implement prevention measures with more solid data. Importantly, this would allow us to optimize therapeutic measures

Detailed description: This study is sponsored and organized by the "group Latin American of interest special in the study of the disease hepatic Alcohol" (ALEH-GLEHA), belonging to the Latin American Association for the study of the hepatic illnesses (ALEH), which is an association non-profit that has nearly 1,000 members from most of the countries of Latin America.

All patients admitted to the hospital with suspected alcoholic hepatitis will be evaluated to see if they can be included in the study. Patients will be enrolled according with the inclusion and exclusion criteria.

The investigators will take a blood sample to be analyzed as part of the necessary data record, for the study of genes and identification of proteins involved in the development, evolution and prognosis of alcoholic hepatitis.

If the medical doctor had instructed to perform a liver biopsy, voluntarily the investigators will ask to participants donate a small share of the surplus of histological sample To achieve this, it is necessary to generate a data bank of clinical information and biological samples (blood, urine, bile, stools, salivary sample or tissue samples) that allows studying the various factors involved in the development and prognosis of this disease in the countries of the Americas.

The investigators will make a clinical follow-up for a year, consisting of phone calls to complete a questionnaire about participant's health. These calls will be made in month 1, 3, 6 and 12 subsequent to participant's hospital discharge.

The data collected are identified by a code and only the study physicians can correlate the data with the participants and medical history, so the participant's identity will not be shared.

There is no financial compensation associated with the study

Eligibility criteria: Inclusion Criteria:

1. Consumption of more than 3 drinks per day (40 g) in women and more than 4 drinks per day (50-60 g) in men.
2. Excessive alcohol consumption for more than 5 years in a row or interrupted.
3. No more than 60 days of abstinence before the onset of jaundice.
4. Bilirubin levels \> 3 mg / dL (\> 50 μmol / L), AST\> 50 IU / mL, AST / ALT ratio\> 1.5.
5. Absence of other causes of hepatic disease.

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy or lactation
3. Alcohol abstinence for more than 60 days before the event that led to hospitalization.
4. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels beyond 400 IU/ml.
5. Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis or Wilson's disease.
6. Hepatocellular carcinoma beyond the Milan criteria (ie, a single lesion \< 5 cm or no more than 3 lesions, the largest of which measures ≤ 3 cm).
7. Extrahepatic neoplasia with a life expectancy of less than 6 months.
8. History of severe extrahepatic disease (eg, chronic kidney failure requiring hemodialysis, severe heart disease (NYHA class ≥ 3), severe chronic lung disease that confers a survival of less than 6 months.
9. Patients who cannot provide informed consent and that lack a responsible legal substitute.

Primary outcomes:
measure: Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days.
timeFrame: 90 days
Secondary outcomes:
measure: Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.)
timeFrame: 4 years
measure: Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score.
timeFrame: 4 years
measure: Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90.
timeFrame: 4 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Unversidad Catolica de Chile
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: juan pablo p arab, md
role: PRINCIPAL_INVESTIGATOR
References: