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NCT Number: NCT07262515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker Hospital

Paris, 75015, France

Location status: Recruiting

Location contact

Camille Luya-Guedj, MSc

CONTACT

[email protected]

Vincent MALLET, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival after diagnosis of acute alcoholic hepatitis

    Time frame: From diagnosis up to 7 years after

    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.

Secondary outcomes

  1. Incidence of bacterial or fungal infections after diagnosis

    Time frame: Within 7 years after diagnosis

    Evaluate the impact of bacterial or fungal infections occurring after diagnosis of acute alcoholic hepatitis on the risk of death

  2. Requirement for liver transplantation

    Time frame: Within 7 years after diagnosis

    Evaluate the influence of the need for liver transplantation after diagnosis of acute alcoholic hepatitis on the risk of death

  3. Organ failure occurrence

    Time frame: within 7 years after diagnosis

    Evaluate the impact of organ failure following a diagnosis of acute alcoholic hepatitis on the risk of death

  4. Impact of alcohol withdrawal on prognosis

    Time frame: within 7 years after diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Luya-Guedj, MSc

CONTACT

[email protected]

0144494327 ext. +33

Vincent MALLET, MD, PhD

CONTACT

[email protected]

01584142453 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: DIONYSOS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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