Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

NCT04077125 | Completed

• 1 other identifier: 1712
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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)

• 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)

• 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)

• 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 Outcomes (6)

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

  baseline

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

  baseline

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

  baseline

• Change in renal artery resistive index after treatment with rifaximin

  at the end of rifaximin treatment (15 days)

• Change in splenic artery resistive index after treatment with rifaximin

  at the end of rifaximin treatment (15 days)

Study Arms (3)

Cirrhosis no MHE

Patients with liver cirrhosis without signs of minimal hepatic encephalopathy

Cirrhosis MHE

Patients with liver cirrhosis with minimal hepatic encephalopathy

Drug: Rifaximin

Controls

Healhty subjects

Interventions

Rifaximin 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)

Cirrhosis MHE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 4, 2019
• Study Start: January 18, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)