A Study of MHE in Patients With Liver Diseases

Completed

• Conditions: Minimal Hepatic Encephalopathy; Hepatic Encephalopathy; Overt Hepatic Encephalopathy
• Interventions: Diagnostic Test: neurophysiological tests, blood biomarkers.

• Registration Number: NCT04058327
• Lead Sponsor: Qin Ning

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no HE group	neurophysiological tests, blood biomarkers.	Patients whose MHE test are negative
MHE group	neurophysiological tests, blood biomarkers.	Patients whose MHE test are positive

Primary Outcome Measures

Name	Time	Method
mortality in short, median and long term	30 and 90 days, 1, 2, 3 years	mortality in 30 days, 90 days, 1 year, 2 years, 3 years
progression of 2-4 HE	30 days	Incidence of HE progression (2/3/4 HE)

Trial Locations

Locations (1)

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