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NCT04058327 Clinical Trial

A Study of MHE in Patients With Liver Diseases

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04058327
Other study ID # MHE study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 30, 2022

Study information
Verified date June 2024
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 252
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• neurophysiological tests, blood biomarkers.
Let the patients do neuropsychological tests and detect blood biomarkers.

Locations
Country Name City State
China Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression of 2-4 HE Incidence of HE progression (2/3/4 HE) 30 days
Primary mortality in short, median and long term mortality in 30 days, 90 days, 1 year, 2 years, 3 years 30 and 90 days, 1, 2, 3 years
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