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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 1 trial group
Group A: Patients with acute alcoholic hepatitis

Trial outcomes

Primary outcomes

1

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.

Time frame
From diagnosis up to 7 years after

Secondary outcomes

1

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

Time frame
Within 7 years after diagnosis
2

Requirement for liver transplantation

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

Time frame
Within 7 years after diagnosis
3

Organ failure occurrence

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

Time frame
within 7 years after diagnosis
4

Impact of alcohol withdrawal on prognosis

Time frame
within 7 years after diagnosis

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Ministry of Health, France

Collaborator