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A Study of MHE in Patients With Liver Diseases

A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04058327
Enrollment
252
Registered
2019-08-15
Start date
2019-05-01
Completion date
2022-12-30
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Overt Hepatic Encephalopathy

Keywords

neurophysiologica tests, diagnosis, minimal hepatic encephalopathy, overt hepatic encephalopathy, liver cirrhosis, acute on chronic liver failure, blood biomarkers

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTneurophysiological tests, blood biomarkers.

Let the patients do neuropsychological tests and detect blood biomarkers.

Sponsors

Qin Ning
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* \>18 years old * cirrhosis * acute on chronic liver failure

Exclusion criteria

(1) 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.

Design outcomes

Primary

MeasureTime frameDescription
progression of 2-4 HE30 daysIncidence of HE progression (2/3/4 HE)
mortality in short, median and long term30 and 90 days, 1, 2, 3 yearsmortality in 30 days, 90 days, 1 year, 2 years, 3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026