Cirrhoses, Liver, Hepatic Encephalopathy, Liver Stiffness, Portal Hypertension Related to Cirrhosis
Conditions
Keywords
Cirrhoses, Liver, Hepatic Encephalopathy, Internal Medicine
Brief 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.
Interventions
None listed
Sponsors
Fadoi Foundation, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Signed informed consent 3. Diagnosis of liver cirrhosis according to recognized clinical, laboratory, and imaging criteria and/or evidence of portal hypertension or liver stiffness ≥ 20 kPa.
Exclusion criteria
* Patient enrolled in other non-observational clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hepatic encephalopathy | through study completion, an average of 1 year | Incidence of both minimal and overt hepatic encephalopathy in patients with liver cirrhosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of screening for minimal hepatic encephalopathy | through study completion, an average of 1 year | Rate of screening for minimal hepatic encephalopathy |
| Rates of in-hospital mortality | from the the discharge untill 9 months | Rates of in-hospital mortality, 3-month and 9-month mortality |
| Readmission rates | from the the discharge untill 9 months | 3-month and 9-month readmission rates post-discharge |
| Rates of counseling | at discharge | Rates of counseling at discharge |
| Description of the treatments for overt hepatic encephalopathy | through study completion, an average of 1 year | Description of the treatments for overt hepatic encephalopathy |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORPAOLA PICCOLO
Internal Medicine Dept. Isola Tiberina Gemelli-Isola Hospital, Rome
Outcome results
None listed