Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Minimal Hepatic Encephalopathy

Interventions

RifaximinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, Italy

Outcomes

Primary Outcomes

Quantification of middle cerebral artery resistive index

Quantification of middle cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

Time frame: baseline

Quantification of middle cerebral artery pulsatility index

Quantification of middle cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

Time frame: baseline

Quantification of posterior cerebral artery resistive index

Quantification of posterior cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

Time frame: baseline

Quantification of posterior cerebral artery pulsatility index

Quantification of posterior cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

Time frame: baseline

Change in middle cerebral artery resistive index after treatment with rifaximin

Variation of middle cerebral artery resistive index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE

Time frame: at the end of rifaximin treatment (15 days)

Change in middle cerebral artery pulsatility index after treatment with rifaximin

Variation of middle cerebral artery pulsatility index measured by Doppler ultrasound after treatment with rifaximin 1200 mg/d for 15 days in patients with liver cirrhosis and MHE

Time frame: at the end of rifaximin treatment (15 days)

Change in posterior cerebral artery resistive index after treatment with rifaximin

Data from ClinicalTrials.gov

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Secondary Outcomes

Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without

Comparison of renal artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without

Time frame: baseline

Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without

Comparison of splenic artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without

Time frame: baseline

Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without

Comparison of endothelial function (flow mediated dilation measured by Doppler ultrasound) of cirrhotic patients with MHE and those without

Time frame: baseline

Change in renal artery resistive index after treatment with rifaximin

Change in renal artery resistive index measured by Doppler ultrasound in patients with liver cirrhosis and MHE after treatment with rifaximin 1200 mg/d for 15 days

Time frame: at the end of rifaximin treatment (15 days)

Change in splenic artery resistive index after treatment with rifaximin

Change in splenic artery resistive index measured by Doppler ultrasound in patients with liver cirrhosis and MHE after treatment with rifaximin 1200 mg/d for 15 days

Time frame: at the end of rifaximin treatment (15 days)

Change in flow mediated dilation after treatment with rifaximin

Change in endothelial function (flow mediated dilation measured by Doppler ultrasound) in patients with liver cirrhosis and MHE after treatment with rifaximin 1200 mg/d for 15 days

Time frame: at the end of rifaximin treatment (15 days)