Clinical trial NCT04077125: Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy
Official title: Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimal Hepatic Encephalopathy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cirrhotic patients evaluated at the Department of Internal Medicine, Gastroenterology and Hepatology of the Fondazione Policlinico A. Gemelli in Rome

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.


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.

Primary outcomes:
measure: Quantification of middle cerebral artery resistive index
timeFrame: baseline
measure: Quantification of middle cerebral artery pulsatility index
timeFrame: baseline
measure: Quantification of posterior cerebral artery resistive index
timeFrame: baseline
measure: Quantification of posterior cerebral artery pulsatility index
timeFrame: baseline
measure: Change in middle cerebral artery resistive index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
measure: Change in middle cerebral artery pulsatility index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
measure: Change in posterior cerebral artery resistive index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
measure: Change in posterior cerebral artery pulsatility index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
Secondary outcomes:
measure: Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without
timeFrame: baseline
measure: Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without
timeFrame: baseline
measure: Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without
timeFrame: baseline
measure: Change in renal artery resistive index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
measure: Change in splenic artery resistive index after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
measure: Change in flow mediated dilation after treatment with rifaximin
timeFrame: at the end of rifaximin treatment (15 days)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
Study officials:
References: