Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)
NCT07150195
Brain Diseases, Brain Diseases, Metabolic
Nanjing, Jiangsu, China
View Trial DetailsNCT Number: NCT07727070
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Ospedale dei Castelli, Ariccia, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 1 year
Incidence of both minimal and overt hepatic encephalopathy in patients with liver cirrhosis
Time frame: through study completion, an average of 1 year
Rate of screening for minimal hepatic encephalopathy
Time frame: from the the discharge untill 9 months
Rates of in-hospital mortality, 3-month and 9-month mortality
Time frame: from the the discharge untill 9 months
3-month and 9-month readmission rates post-discharge
Time frame: at discharge
Rates of counseling at discharge
Time frame: through study completion, an average of 1 year
Description of the treatments for overt hepatic encephalopathy
Fadoi Foundation, Italy
Other
A Prospective Observational Multicenter Study of the Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Acronym: HEPTAGON
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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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