NCT04142723

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 2, 2019

Last Update Submit

October 25, 2019

Conditions

Hepatitis, Alcoholic

Keywords

alcoholic, liver disease, cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of subjects hospitalized with alcoholic hepatitis who die at 30, 60 and 90 days.

    To determine the clinical characteristics, complications and in-hospital mortality of patients who are hospitalized for alcoholic hepatitis in different establishments in America. 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. This will help us to know aspects of the highest prevalence and mortality from alcoholic hepatitis in Latin Americans in comparison to other regions of the world and useful information in the prevention and early diagnosis of this disease.

    90 days

Secondary Outcomes (3)

  • Number of subjects hospitalized with alcoholic hepatitis who develop complications (infection, gastrointestinal bleeding, renal failure, etc.)

    4 years

  • Number of subjects with alcoholic hepatitis who are cataloged as responders by Lille score.

    4 years

  • Mean Model of End-Stage Liver Disease (MELD) score at day 0, 30, 60 and 90.

    4 years

Interventions

blood withdrawBIOLOGICAL

venous blood sampling

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consumption of more than 3 drinks per day in women and more than 4 drinks per day in men

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • Pregnancy or lactation
  • Alcohol abstinence for more than 60 days before the event that led to hospitalization.
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels beyond 400 IU/ml.
  • Presence of drug-induced liver injury (DILI), ischemic hepatitis, biliary duct obstruction, viral hepatitis, autoimmune hepatitis or Wilson's disease.
  • 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).
  • Extrahepatic neoplasia with a life expectancy of less than 6 months.
  • 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.
  • Patients who cannot provide informed consent and that lack a responsible legal substitute.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Unversidad Catolica de Chile

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Hepatitis, AlcoholicLiver DiseasesFibrosis

Condition Hierarchy (Ancestors)

HepatitisDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • juan pablo p arab, md

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan pablo p arab, MD

CONTACT

56223543845jparab@gmail.com

Juan Pablo P Roblero, MD

CONTACT

56223543845jroblero@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 29, 2019

Study Start

June 20, 2019

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

CL(1)