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Alcoholic Hepatitis in Latin-...

Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-20

Study Completion Date

2022-06-20

Brief Summary

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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

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Detailed Description

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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

Conditions

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Hepatitis, Alcoholic

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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blood withdraw

venous blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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juan pablo p arab, md

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

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Hospital Clinico Unversidad Catolica de Chile

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Juan pablo p arab, MD

Role: CONTACT

[email protected]

56223543845 ext. 3845

Juan Pablo P Roblero, MD

Role: CONTACT

[email protected]

56223543845 ext. 3845

Facility Contacts

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juan p arab, MD

Role: primary

[email protected]

56223543845 ext. 3845

juan p roblero, MD

Role: backup

[email protected]

56223543845 ext. 3845

Other Identifiers

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Alcoholic Hepatitis

Identifier Type: -

Identifier Source: org_study_id

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Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).

Study Results

Basic Information

Brief Summary

Related Clinical Trials

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Detailed Description

Conditions

Study Design

Interventions

blood withdraw

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

ALEH

Hospital Nacional Hipolito

Hospital Goyoneche Arequipa

Hospital Nacional Edgardo Rebagliati Martins

HBCASE

Hospital Regional Honorio Delgado Arequipa Peru

Hospital Nacional Daniel Alcides Carrión - Callao

Instituto de Gastroenterología

Hospital Docente Clinico Quirurgico:Manuel Piti Fajardo

Hospital de Clínicas D. N. Avellaneda

Hospital Padilla. Tucuman

Hospital Pablo Soria. Jujuy

FUNDACIÓN SAYANI

Hospital Italiano Buenos Aires

Rosario

Hospital de Gastroenterología Dr Carlos Bonorino Udaondo

Hospital Austral de Buenos Aires

Francisco Alfonso Solís Galindo

Centro de Investigación en Enfermedades Hepáticas y Gastroenterología

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Hospital General de Mexico

Hospital Eugenio Espejo

Hospital de Especialidades de las FF.AA Quito

Hospital Carlos Andrade Marín

Hospital General San Juan de Dios

Hospital Roosevelt

Hospital San Vicente Fundación Medellín

Clinica Universitaria Colombia

Hospital San Vicente Fundación - Rionegro

Fundacion Cardioinfantil

Hospital Pablo Tobon Uribe. Univ. De Antioquia

Fundação Hospital Adriano Jorge

Hospital do Rocio

Hospital das Clinacas Riberao Preto

Universidade Estadual Paulista (UNESP) - Botucatu/São Paulo

FUNDHACRE- Serviço de Assistência Especializada- Acre

Hospital Getúlio Vargas - Teresina/Piauí

Hospital do Servidor Público Estadual - São Paulo/São Paulo

Hospital Federal de Bonsucesso - Rio de Janeiro/Rio de Janeiro

CHP/ Cl Davila / HCUH

Hospital San Juan de Dios

Hospital Sotero Del Rio

Hospital San Borja-Arriaran

University of Chile

Hospital Clinico Universidad Catolica

Hospital de Concepcion

Hospital Escuela

Pontificia Universidad Catolica de Chile

Responsible Party

Principal Investigators

juan pablo p arab, md

Locations

Hospital Clinico Unversidad Catolica de Chile

Countries

Central Contacts

Juan pablo p arab, MD

Juan Pablo P Roblero, MD

Facility Contacts

juan p arab, MD

juan p roblero, MD

Other Identifiers