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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04077125
Other study ID # 1712
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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