protocolSection identificationModule nctId: NCT06358196, orgStudyIdInfo id: CESAH, briefTitle: Complex Exploratory Study of Alcohol-Associated Hepatitis, acronym: CESAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Pavol Jozef Safarik University, class: OTHER, collaborators name: L Pasteur University Hospital, collaborators name: Hospital Agel Kosice-Saca, collaborators name: Technical University in Kosice, collaborators name: Western University, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: 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., conditionsModule conditions: Alcoholic Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area, secondaryOutcomes measure: Threshold of alcohol consumption associated with (an increased risk of) developing AH, secondaryOutcomes measure: Diagnostic accuracy of NIAAA and NIAAAm-CRP, secondaryOutcomes measure: Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score, secondaryOutcomes measure: Prognostic performance of SOFA and CLIF-C, secondaryOutcomes measure: An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score, secondaryOutcomes measure: Alternative to Lille model, secondaryOutcomes measure: Prognostic model for 90 day survival, secondaryOutcomes measure: Uper limit of MELD or Maddrey scores beyond which patients no longer derive any therapeutic benefit from corticosteroid treatment, secondaryOutcomes measure: Natural course of nonsevere alcoholic hepatitis, secondaryOutcomes measure: Natural course of severe alcoholic hepatitis, secondaryOutcomes measure: Risk score for bacterial infection before corticosteroid treatment in patients with alcoholic hepatitis, secondaryOutcomes measure: Distinguishing sterile Inflammation from infection in alcoholic hepatitis, secondaryOutcomes measure: GUT microbiome and treatment response in alcoholic hepatitis, secondaryOutcomes measure: Hypothalamus-pituitary-adrenal axis and treatment response in alcoholic hepatitis, secondaryOutcomes measure: Adherence to outpatient psychiatric management, secondaryOutcomes measure: Nutritional status and treatment response in alcoholic hepatitis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pavol Jozef Safarik University, city: Kosice, zip: 04012, country: Slovakia, contacts name: Jakub Gazda, MD, PhD, role: CONTACT, phone: +421911115288, email: jakub.gazda@upjs.sk, contacts name: Martin Janicko, MD, PhD, role: CONTACT, email: martin.janicko@upjs.sk, geoPoint lat: 48.71395, lon: 21.25808, hasResults: False