Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Minimal Hepatic Encephalopathy Clinical Trial

Official title:

Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077125
• Other study ID #: 1712
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: August 2019
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Minimal Hepatic Encephalopathy

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Primary	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	baseline
Primary	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	baseline
Primary	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	baseline
Primary	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	at the end of rifaximin treatment (15 days)
Primary	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	at the end of rifaximin treatment (15 days)
Primary	Change in posterior cerebral artery resistive index after treatment with rifaximin	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	at the end of rifaximin treatment (15 days)
Primary	Change in posterior cerebral artery pulsatility index after treatment with rifaximin	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	at the end of rifaximin treatment (15 days)
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	at the end of rifaximin treatment (15 days)
Secondary	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	at the end of rifaximin treatment (15 days)
Secondary	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	at the end of rifaximin treatment (15 days)