A Study of MHE in Patients With Liver Diseases

NCT04058327 | Completed

• 1 other identifier: MHE study
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

MHE group

Patients whose MHE test are positive

Diagnostic Test: neurophysiological tests, blood biomarkers.

no HE group

Patients whose MHE test are negative

Diagnostic Test: neurophysiological tests, blood biomarkers.

Interventions

neurophysiological tests, blood biomarkers. DIAGNOSTIC_TEST

Let the patients do neuropsychological tests and detect blood biomarkers.

MHE group; no HE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis, acute on chronic liver failure

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be restored in central lab

MeSH Terms

Conditions

Hepatic Encephalopathy; Disease; Liver Cirrhosis; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Liver Failure, Acute

Study Officials

• Qin Ning, MD., PhD.

  Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Infectious Diseases

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 15, 2019
• Study Start: May 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (1)