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Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT04077125
Recruitment Status : Completed
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Francesca Ponziani, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.


Condition or disease Intervention/treatment
Minimal Hepatic Encephalopathy Drug: Rifaximin

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
Actual Study Start Date : January 18, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Group/Cohort Intervention/treatment
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
to investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d)

Controls
Healhty subjects



Primary Outcome Measures :
  1. Quantification of middle cerebral artery resistive index [ Time Frame: baseline ]
    Quantification of middle cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

  2. Quantification of middle cerebral artery pulsatility index [ Time Frame: baseline ]
    Quantification of middle cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

  3. Quantification of posterior cerebral artery resistive index [ Time Frame: baseline ]
    Quantification of posterior cerebral artery resistive index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

  4. Quantification of posterior cerebral artery pulsatility index [ Time Frame: baseline ]
    Quantification of posterior cerebral artery pulsatility index by Doppler ultrasound in patients with liver cirrhosis with or without MHE

  5. Change in middle cerebral artery resistive index after treatment with rifaximin [ Time Frame: 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

  6. Change in middle cerebral artery pulsatility index after treatment with rifaximin [ Time Frame: 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

  7. Change in posterior cerebral artery resistive index after treatment with rifaximin [ Time Frame: 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

  8. Change in posterior cerebral artery pulsatility index after treatment with rifaximin [ Time Frame: 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


Secondary Outcome Measures :
  1. Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without [ Time Frame: baseline ]
    Comparison of renal artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without

  2. Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without [ Time Frame: baseline ]
    Comparison of splenic artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without

  3. Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without [ Time Frame: baseline ]
    Comparison of endothelial function (flow mediated dilation measured by Doppler ultrasound) of cirrhotic patients with MHE and those without

  4. Change in renal artery resistive index after treatment with rifaximin [ Time Frame: 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

  5. Change in splenic artery resistive index after treatment with rifaximin [ Time Frame: 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

  6. Change in flow mediated dilation after treatment with rifaximin [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077125


Locations
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Italy
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Responsible Party: Francesca Ponziani, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04077125    
Other Study ID Numbers: 1712
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents