Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP (DIONYSOS)

Acute alcoholic hepatitis (AAH) is a severe liver disease that often occurs in individuals with prolonged excessive alcohol consumption. Patients face a high risk of liver failure, complications, and death, despite available treatments. Current prognostic scores based on blood tests provide limited accuracy and do not capture the full complexity of the disease.

The purpose of this study is to improve the prediction of patient outcomes after a diagnosis of acute alcoholic hepatitis. By integrating clinical, biological, and histological information collected from the AP-HP data warehouse, the investigators aim to identify more reliable prognostic markers. This could help physicians better tailor treatments and improve survival of patients affected by this condition.

Study Overview

• Status: Recruiting
• Conditions: Acute Alcoholic Hepatitis

Detailed Description

Acute alcoholic hepatitis (AAH) is characterized by acute liver inflammation caused by prolonged excessive alcohol intake. It is associated with jaundice, liver failure, and in severe cases, multi-organ failure and death. Current prognostic scores rely primarily on serum biomarkers of liver function but fail to account for systemic complications or histological features.

This retrospective, multicenter observational study conducted at AP-HP hospitals will analyze a large cohort of patients diagnosed with AAH since 2017. Data extracted from the AP-HP Clinical Data Warehouse (EDS) will include demographics, comorbidities, biological markers (liver and renal function tests, coagulation parameters, lactate), histological findings (necrosis, fibrosis, neutrophil infiltration, bilirubinostasis), microbiology results, prescribed medications, and outcomes such as infections, need for liver transplantation, and mortality.

The primary outcome is overall survival after diagnosis. Secondary outcomes include the impact of intermediate factors such as bacterial or fungal infections, alcohol withdrawal, organ failure, and transplantation on prognosis. Statistical analyses will combine classical survival models (Cox regression, Accelerated Failure Time models) and modern machine learning approaches (random forest, gradient boosting).

The goal is to develop integrative prognostic models that provide a more accurate and personalized assessment of prognosis in AAH, ultimately guiding clinical decision-making and improving patient management.

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Vincent MALLET, MD, PhD; Phone Number: +33 01584142453; Email: vincent.mallet@aphp.fr
• Study Contact Backup: Name: Camille Luya-Guedj, MSc; Phone Number: +33 0144494327; Email: camille.luya-guedj@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Necker Hospital
    • Contact: Vincent MALLET, MD, PhD; Email: vincent.mallet@aphp.fr
    • Contact: Camille Luya-Guedj, MSc; Email: camille.luya-guedj@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute alcoholic hepatitis across all AP-HP hospitals. Data will be collected retrospectively from the AP-HP Clinical Data Warehouse (EDS).

Description

Inclusion Criteria:

• Adult patients (≥18 years)
• Diagnosis of acute alcoholic hepatitis (ICD10 K701 or occurrence of the terms "HAA" (French translation of "AAH" or "hépatite alcoolique aiguë" (French translation of "acute alcoholic hepatitis") in a pathology report, followed by manual verification

Exclusion Criteria:

- Patients younger than 18 years at diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with acute alcoholic hepatitis; All adult patients diagnosed with acute alcoholic hepatitis at AP-HP hospitals, identified using ICD-10 codes (K701), pathology reports, and clinical data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival after diagnosis of acute alcoholic hepatitis	Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of acute alcoholic hepatitis, by integrating clinical, biological, and histological information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.	From diagnosis up to 7 years after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bacterial or fungal infections after diagnosis	Evaluate the impact of bacterial or fungal infections occurring after diagnosis of acute alcoholic hepatitis on the risk of death	Within 7 years after diagnosis
Requirement for liver transplantation	Evaluate the influence of the need for liver transplantation after diagnosis of acute alcoholic hepatitis on the risk of death	Within 7 years after diagnosis
Organ failure occurrence	Evaluate the impact of organ failure following a diagnosis of acute alcoholic hepatitis on the risk of death	within 7 years after diagnosis
Impact of alcohol withdrawal on prognosis		within 7 years after diagnosis

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France; URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Vincent MALLET, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Machine Learning; Acute Alcoholic Hepatitis; RWE epidemiology; Prognosis prediction; Accelerated failure time
• Other Study ID Numbers: DAT23012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No