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ACTIVE NOT RECRUITING
NCT07727070

Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine

Sponsor: Fadoi Foundation, Italy

View on ClinicalTrials.gov

Summary

Patients with decompensated liver cirrhosis are mostly managed in Internal Medicine outpatient clinics and wards; among these patients, overt hepatic encephalopathy represents one of the most frequent causes of emergency hospital admission. Furthermore, hospitalizations for decompensated cirrhosis are expected to increase steadily, given the progressive rise in chronic liver diseases of metabolic and alcohol-related origin. Therefore, the skills of the Internal Medicine physician must increasingly include screening for minimal hepatic encephalopathy, identification and treatment of overt hepatic encephalopathy, and prevention of relapses. In view of the lack of data from prospective studies on the incidence, management, and outcomes of hepatic encephalopathy in patients admitted to Internal Medicine wards in Italy, it is considered important to collect and analyze a large case series in order to identify critical issues in management during hospitalization and at discharge, also with the aim of preventing rehospitalizations. On this basis, Fondazione FADOI has decided to promote the FADOI-HEPTAGON study, a prospective, multicenter, observational study involving approximately 45 Internal Medicine Units across Italy, which will competitively enroll at least 400 consecutive inpatient cases of liver cirrhosis over a one-year period, collecting data on management, treatment, and clinical outcomes during the acute phase and at 3 and 9 months after discharge (follow-up). Among these subjects, patients with hepatic encephalopathy will also be identified in order to assess its incidence.

Official title: A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-12-05

Completion Date

2027-08

Last Updated

2026-07-27

Healthy Volunteers

No

Locations (41)

Ospedale dei Castelli

Ariccia, Italy

Ospedale "Luigi Cazzavillan"

Arzignano, Italy

Ospedale di Assisi

Assisi, Italy

IRCCS Azienda Ospedaliera-Universitaria Policlinico "S. Orsola"

Bologna, Italy

Ospedale Centrale di Bolzano

Bolzano, Italy

Ospedale "A. Perrino"

Brindisi, Italy

Ospedale "Santo Spirito"

Casale Monferrato, Italy

Azienda Ospedaliero Universitaria "Renato Dulbecco"

Catanzaro, Italy

Ospedale "Cervesi"

Cattolica, Italy

Ospedale Maggiore

Chieri, Italy

Ospedale di Cremona

Cremona, Italy

Ospedale "San Giovanni di Dio"

Crotone, Italy

Ospedale di Dolo

Dolo, Italy

Ospedale del Delta

Ferrara, Italy

Ospedale "S. Maria Annunziata"

Florence, Italy

Ospedale "Sacro Cuore di Gesù"

Gallipoli, Italy

Ospedale della Misericordia

Grosseto, Italy

Ospedale "Sant'Andrea"

Lamezia Terme, Italy

Ospedale Civile di Legnano

Legnano, Italy

P.O. di Livorno

Livorno, Italy

Ospedale "Umberto I°" di Lugo

Lugo, Italy

Presidio Ospedaliero "San Salvatore"

L’Aquila, Italy

Azienda Ospedaliera "Carlo Poma"

Mantua, Italy

Ospedale Fatebenefratelli e Oftalmico

Milan, Italy

Ospedali Riuniti Padova Sud

Monselice, Italy

AORN "A. Cardarelli"

Naples, Italy

Ospedale "Vincenzo Monaldi" - AOS dei Colli

Naples, Italy

Ospedale "Umberto I°" di Nocera

Nocera Inferiore, Italy

AOU "Maggiore della Carità"

Novara, Italy

Ospedale "Buccheri-La Ferla" Fatebenefratelli

Palermo, Italy

Ospedale Di Camerino

Province of Macerata, Italy

Ospedale "Santa Maria delle Croci"

Ravenna, Italy

Isola Tiberina Gemelli-Isola Hospital, Rome

Roma, Italy

Ospedale "S. Maria della Misericordia"

Rovigo, Italy

Ospedale "Girolamo Fracastoro"

San Bonifacio, Italy

P.O. "SS. Annunziata"

Sassari, Italy

Ospedale "San Paolo"

Savona, Italy

Ospedale "Umberto I°" di Siracusa

Syracuse, Italy

Ospedale Civile "Giuseppe Mazzini"

Teramo, Italy

Ospedale di Circolo di Varese

Varese, Italy

Ospedale Civile di Voghera

Voghera, Italy