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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07262515
Acronym
DIONYSOS
Enrollment
1400
Registered
2025-12-03
Start date
2024-07-19
Completion date
2025-12-31
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Alcoholic Hepatitis

Keywords

Acute Alcoholic Hepatitis, Machine Learning, Accelerated failure time, RWE epidemiology, Prognosis prediction

Brief summary

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.

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.

Interventions

None listed

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Ministry of Health, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival after diagnosis of acute alcoholic hepatitisFrom diagnosis up to 7 years afterOverall 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

MeasureTime frameDescription
Requirement for liver transplantationWithin 7 years after diagnosisEvaluate the influence of the need for liver transplantation after diagnosis of acute alcoholic hepatitis on the risk of death
Incidence of bacterial or fungal infections after diagnosisWithin 7 years after diagnosisEvaluate the impact of bacterial or fungal infections occurring after diagnosis of acute alcoholic hepatitis on the risk of death
Organ failure occurrencewithin 7 years after diagnosisEvaluate the impact of organ failure following a diagnosis of acute alcoholic hepatitis on the risk of death
Impact of alcohol withdrawal on prognosiswithin 7 years after diagnosis

Countries

France

Contacts

Primary ContactVincent MALLET, MD, PhD
vincent.mallet@aphp.fr01584142453
Backup ContactCamille Luya-Guedj, MSc
camille.luya-guedj@aphp.fr0144494327

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026