Minimal Hepatic EncephalopathyNCT04077125
Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy
An observational study of Minimal Hepatic Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Rifaximin
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All cirrhotic patients evaluated at the Department of Internal Medicine, Gastroenterology and Hepatology of the Fondazione Policlinico A. Gemelli in Rome
Who may be able to join
- diagnosis of liver cirrhosis on the basis of clinical, laboratory and ultrasound findings
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
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.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
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 group | Role | What they receive |
|---|---|---|
| Cirrhosis no MHE | Patients with liver cirrhosis without signs of minimal hepatic encephalopathy | |
| Cirrhosis MHE | Patients with liver cirrhosis with minimal hepatic encephalopathy Receives: Drug: Rifaximin | |
| Controls | Healhty subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at the end of rifaximin treatment (15 days)
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
Measured: 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
Measured: at the end of rifaximin treatment (15 days)
Secondary outcomes (6)
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
Measured: baseline
Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without
Comparison of splenic artery resistive index measured by Doppler ultrasound of cirrhotic patients with MHE and those without
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at the end of rifaximin treatment (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start18 Jan 2018
- Primary completion31 Dec 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Ponziani, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077125
- Sponsor's protocol ID
- 1712
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Hepatic Encephalopathy is Associated With Increased Cerebral Vascular Resistance. a Transcranial Doppler Ultrasound Study
- ClinicalTrials.gov ID
- NCT04077125
- Acronym / sponsor ID
- 1712
- Conditions
- Minimal Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis no MHE | – | –Patients with liver cirrhosis without signs of minimal hepatic encephalopathy |
| Cirrhosis MHE | – | Drug: RifaximinPatients with liver cirrhosis with minimal hepatic encephalopathy |
| Controls | – | –Healhty subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All cirrhotic patients evaluated at the Department of Internal Medicine, Gastroenterology and Hepatology of the Fondazione Policlinico A. Gemelli in Rome
Key inclusion criteria (1 listed)
- diagnosis of liver cirrhosis on the basis of clinical, laboratory and ultrasound findings
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximinto investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d) | Drug | Cirrhosis MHE |
Primary outcome
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
6 secondary outcomes
Comparison of renal artery resistive index of cirrhotic patients with MHE compared to those without
Time frame: baseline
Comparison of splenic artery resistive index of cirrhotic patients with MHE compared to those without
Time frame: baseline
Comparison of flow mediated dilation of cirrhotic patients with MHE compared to those without
Time frame: baseline
Change in renal artery resistive index after treatment with rifaximin
Time frame: at the end of rifaximin treatment (15 days)
Change in splenic artery resistive index after treatment with rifaximin
Time frame: at the end of rifaximin treatment (15 days)
Change in flow mediated dilation after treatment with rifaximin
Time frame: at the end of rifaximin treatment (15 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Hepatic Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of middle cerebral artery resistive index (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.