Minimal Hepatic Encephalopathy
Conditions
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.
Interventions
DRUGRifaximin
to investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d)
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed