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Completed

NCT Number: NCT04077125

Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

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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Key information

Conditions

Minimal Hepatic Encephalopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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