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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

Tracking Information
First Submitted Date August 28, 2019
First Posted Date September 4, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date January 18, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 30, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy
Official Title Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Minimal Hepatic Encephalopathy
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)
Study Groups/Cohorts
  • Cirrhosis no MHE
    Patients with liver cirrhosis without signs of minimal hepatic encephalopathy
  • Cirrhosis MHE
    Patients with liver cirrhosis with minimal hepatic encephalopathy
    Intervention: Drug: Rifaximin
  • Controls
    Healhty subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2019)
100
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04077125
Other Study ID Numbers 1712
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Francesca Ponziani, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verification Date August 2019