Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

NCT ID: NCT04077125

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2019-03-01

Brief Summary

Minimal hepatic encephalopathy (MHE) is a subclinical complication of liver cirrhosis with a relevant social impact. Thus, there is urgent need to implement easy to use diagnostic tools for the early identification of affected patients.

This study was aimed to investigate cerebral blood flow, systemic hemodynamics as well as endothelial function of cirrhotic patients with MHE, and to verify their change after treatment with rifaximin.

Conditions

Minimal Hepatic Encephalopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cirrhosis no MHE

Patients with liver cirrhosis without signs of minimal hepatic encephalopathy

No interventions assigned to this group

Cirrhosis MHE

Patients with liver cirrhosis with minimal hepatic encephalopathy

Rifaximin

Intervention Type: DRUG

to investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d)

Controls

Healhty subjects

No interventions assigned to this group

Interventions

Rifaximin

to investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• diagnosis of liver cirrhosis on the basis of clinical, laboratory and ultrasound findings

Exclusion Criteria

• active alcohol abuse (excessive alcohol intake stopped more than 6 months before the enrollment);
• chronic pulmonary diseases; ongoing infections; cerebrovascular diseases; primary or secondary cerebral neoplasm; primary liver neoplasm; heart function failure; chronic kidney disease; peripheral vascular disease; treatment with rifaximin or systemic antibiotics in the previous 15 days;
• smoking habit;
• grade 1 or overt hepatic encephalopathy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Francesca Ponziani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

1712

Identifier Type: -

Identifier Source: org_study_id