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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Encephalopathy; Minimal Hepatic Encephalopathy; Overt Hepatic Encephalopathy
• Intervention / Treatment: Diagnostic test: neurophysiological tests, blood biomarkers.

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 Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis, acute on chronic liver failure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MHE group; Patients whose MHE test are positive	Diagnostic test: neurophysiological tests, blood biomarkers.; Let the patients do neuropsychological tests and detect blood biomarkers.
no HE group; Patients whose MHE test are negative	Diagnostic test: neurophysiological tests, blood biomarkers.; Let the patients do neuropsychological tests and detect blood biomarkers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of 2-4 HE	Incidence of HE progression (2/3/4 HE)	30 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver disease progression	Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)	1 year

Collaborators and Investigators

• Sponsor: Qin Ning
• Investigators: Study Chair: Qin Ning, MD., PhD., Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: diagnosis; blood biomarkers; liver cirrhosis; acute on chronic liver failure; minimal hepatic encephalopathy; overt hepatic encephalopathy; neurophysiologica tests
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic; Liver Diseases; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: MHE study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No