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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhosis no MHE | Patients with liver cirrhosis without signs of minimal hepatic encephalopathy | ||
| Cirrhosis MHE | Patients with liver cirrhosis with minimal hepatic encephalopathy |
| |
| Controls | Healhty subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without |
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Inclusion Criteria:
Exclusion Criteria:
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All cirrhotic patients evaluated at the Department of Internal Medicine, Gastroenterology and Hepatology of the Fondazione Policlinico A. Gemelli in Rome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli IRCCS | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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) |
Comparison of splenic artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without |
| baseline |
| 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 |
| 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) |
| 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) |
| 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) |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |