Hepatic EncephalopathyNCT04058327
A Study of MHE in Patients With Liver Diseases
An observational study of Hepatic Encephalopathy and Minimal Hepatic Encephalopathy, run by Qin Ning at 1 site in China.
Trial summary
The study analyzes the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predicts risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Overt Hepatic Encephalopathy
- What is being tested?
- neurophysiological tests, blood biomarkers.
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Dec 2022
- 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: Patients with cirrhosis, acute on chronic liver failure
Who may be able to join
- >18 years old
- cirrhosis
- acute on chronic liver failure
Who cannot join
- status of OHE; (2) accompanying nervous system diseases, such as dementia or stroke; (3) a history of recent head trauma or surgery, and (4) organic lesions in the brain, such as haemorrhages or infarction; (5) inability to finish the psychometric hepatic encephalopathy score (PHES), such as unable to observe patterns or words clearly on paper, and (6) a recent transjugular intrahepatic portosystemic shunt (TIPS) or abdominal imaging demonstrated portosystemic shunts, and (7) high alcohol consumption (> 30 g/day in men or 20 g/day in women) or psychoactive medication consumption in the past four weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases
The study analyzes the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predicts risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
Read the detailed description
Hepatic encephalopathy (HE) is a common complication and one of the most serious manifestations of cirrhosis and acute on chronic liver failure, not only increasing the risks of death, but also seriously affecting the lives of the patients and their caregivers. Minimal hepatic encephalopathy (MHE), the earliest stage of HE, despite its undiscernible clinical evidence, it is related with abnormalities of patients' daily cognition, emotion, muscular strength, driving ability, quality of life and socioeconomic status At present. However, MHE is not easy to diagnose in daily clinical work because of time-consuming psychometric tests, especially the inconvenience of application in weak inpatients. This study aims to analyze the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predict risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
- Being tested
- neurophysiological tests, blood biomarkers.
- Keywords
- neurophysiologica tests, diagnosis, minimal hepatic encephalopathy, overt hepatic encephalopathy, liver cirrhosis, acute on chronic liver failure, blood biomarkers
- Medical subject headings
- Hepatic Encephalopathy, Disease, Liver Cirrhosis, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurophysiological tests, blood biomarkers.Diagnostic test
Let the patients do neuropsychological tests and detect blood biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| MHE group | Patients whose MHE test are positive Receives: Diagnostic Test: neurophysiological tests, blood biomarkers. | |
| no HE group | Patients whose MHE test are negative Receives: Diagnostic Test: neurophysiological tests, blood biomarkers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of 2-4 HE
Incidence of HE progression (2/3/4 HE)
Measured: 30 days
mortality in short, median and long term
mortality in 30 days, 90 days, 1 year, 2 years, 3 years
Measured: 30 and 90 days, 1, 2, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 May 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, MD., PhD., Study chair, Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058327
- Sponsor's protocol ID
- MHE study
- Status last verified
- Jun 2024
- First submitted
- 11 Aug 2019
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases
- ClinicalTrials.gov ID
- NCT04058327
- Acronym / sponsor ID
- MHE study
- Keywords
- neurophysiologica tests, diagnosis, minimal hepatic encephalopathy, overt hepatic encephalopathy, liver cirrhosis, acute on chronic liver failure, blood biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 15 Aug 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.
The study analyzes the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predicts risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
Detailed description
Hepatic encephalopathy (HE) is a common complication and one of the most serious manifestations of cirrhosis and acute on chronic liver failure, not only increasing the risks of death, but also seriously affecting the lives of the patients and their caregivers. Minimal hepatic encephalopathy (MHE), the earliest stage of HE, despite its undiscernible clinical evidence, it is related with abnormalities of patients' daily cognition, emotion, muscular strength, driving ability, quality of life and socioeconomic status At present. However, MHE is not easy to diagnose in daily clinical work because of time-consuming psychometric tests, especially the inconvenience of application in weak inpatients. This study aims to analyze the diagnostic efficacy of neurophysiological tests and blood biomarkers on MHE, predict risk factors on the development of OHE and investigate the mortality of MHE in patients with cirrhosis and acute on chronic liver failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHE group | – | Diagnostic Test: neurophysiological tests, blood biomarkers.Patients whose MHE test are positive |
| no HE group | – | Diagnostic Test: neurophysiological tests, blood biomarkers.Patients whose MHE test are negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis, acute on chronic liver failure
Key inclusion criteria (3 listed)
- >18 years old
- cirrhosis
- acute on chronic liver failure
Key exclusion criteria (1 listed)
- status of OHE; (2) accompanying nervous system diseases, such as dementia or stroke; (3) a history of recent head trauma or surgery, and (4) organic lesions in the brain, such as haemorrhages or infarction; (5) inability to finish the psychometric hepatic encephalopathy score (PHES), such as unable to observe patterns or words clearly on paper, and (6) a recent transjugular intrahepatic portosystemic shunt (TIPS) or abdominal imaging demonstrated portosystemic shunts, and (7) high alcohol consumption (> 30 g/day in men or 20 g/day in women) or psychoactive medication consumption in the past four weeks.
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 |
|---|---|---|
| neurophysiological tests, blood biomarkers.Let the patients do neuropsychological tests and detect blood biomarkers. | Diagnostic test | MHE group, no HE group |
Primary outcome
progression of 2-4 HE
Time frame: 30 days
Incidence of HE progression (2/3/4 HE)
mortality in short, median and long term
Time frame: 30 and 90 days, 1, 2, 3 years
mortality in 30 days, 90 days, 1 year, 2 years, 3 years
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 17 Jun 2024.
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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.
Qin Ning, MD., PhD. study chair
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
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 Hepatic Encephalopathy and Minimal Hepatic Encephalopathy, run by Qin Ning at 1 site in China.
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 3 inclusion and 1 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 17 Jun 2024. 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 China. 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?
progression of 2-4 HE (time frame: 30 days). The study lists 2 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 17 Jun 2024.