Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Completed

• Conditions: Minimal Hepatic Encephalopathy
• Interventions: Drug: Rifaximin

• Registration Number: NCT04077125
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Study First Posted: 2019-09-04
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis MHE	Rifaximin	Patients with liver cirrhosis with minimal hepatic encephalopathy

Primary Outcome Measures

Name	Time	Method
Quantification of middle cerebral artery resistive index	baseline	Quantification of middle cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Quantification of middle cerebral artery pulsatility index	baseline	Quantification of middle cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in posterior cerebral artery pulsatility index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	Variation of posterior 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
Quantification of posterior cerebral artery resistive index	baseline	Quantification of posterior cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in middle cerebral artery pulsatility index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	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
Quantification of posterior cerebral artery pulsatility index	baseline	Quantification of posterior cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE
Change in middle cerebral artery resistive index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	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
Change in posterior cerebral artery resistive index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	Variation of posterior 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

Secondary Outcome Measures

Name	Time	Method
Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without	baseline	Comparison of endothelial function (flow mediated dilation measured by Doppler ultrasound) of cirrhotic patients with MHE and those without
Change in renal artery resistive index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	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
Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without	baseline	Comparison of renal artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without
Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without	baseline	Comparison of splenic artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without
Change in splenic artery resistive index after treatment with rifaximin	at the end of rifaximin treatment (15 days)	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
Change in flow mediated dilation after treatment with rifaximin	at the end of rifaximin treatment (15 days)	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

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy