Complex Exploratory Study of Alcohol-Associated Hepatitis

NCT06358196 | Not Yet Recruiting DMC

• 1 other identifier: CESAH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis. It is associated with high mortality and characterized by an absence of effective treatment, while corticosteroids, which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval. The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims.

Conditions

Alcoholic Hepatitis

Keywords

alcoholic hepatitis; prognosis; epidemiology; treatment; hypothalamus-hypopituitary-adrenal axis; gut-Liver Microbiome Axis; nutritional status

Outcome Measures

Primary Outcomes (1)

• Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area

  Number of patients with (severe) alcoholic hepatitis

  1 year

Secondary Outcomes (16)

• Threshold of alcohol consumption associated with (an increased risk of) developing AH

  Baseline

• Diagnostic accuracy of NIAAA and NIAAAm-CRP

  Baseline

• Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score

  Baseline, Days 2, 4, 7

• Prognostic performance of SOFA and CLIF-C

  Baseline, Days 2, 4, 7

• An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score

  Baseline

Study Arms (1)

Alcohol-associated hepatitis patients

Inclusion criterion • Patients older than 18 years with acute liver injury / acute liver failure with later confirmation of the AH diagnosis according to the NIAAA diagnostic criteria \[14\] who provided written informed consents for admission and further differentiation, and for study participation Exclusion criteria * Patients not confirmed to have alcohol-associated hepatitis * Patients with malignancies (specifically those with life-expectancy limitation) * Patients who withdrew consent for study participation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Alcohol-Associated Hepatitis

You may qualify if:

• Patients older than 18 years with acute liver injury / acute liver failure with later confirmation of the AH diagnosis according to the NIAAA diagnostic criteria \[14\] who provided written informed consents for admission and further differentiation, and for study participation

You may not qualify if:

• Patients not confirmed to have alcohol-associated hepatitis
• Patients with malignancies (specifically those with life-expectancy limitation)
• Patients who withdrew consent for study participation

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead
• L Pasteur University Hospital: collaborator
• Hospital Agel Kosice-Saca: collaborator
• Technical University in Kosice: collaborator
• Western University: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (1)

Pavol Jozef Safarik University

Košice, 04012, Slovakia

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jakub Gazda, MD, PhD

  Pavol Jozef Safarik University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Gazda, MD, PhD

CONTACT

+421911115288; jakub.gazda@upjs.sk

Martin Janicko, MD, PhD

CONTACT

martin.janicko@upjs.sk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 10, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)