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A Study of MHE in Patients With Liver Diseases

Q

Qin Ning

Status

Completed

Conditions

Overt Hepatic Encephalopathy
Minimal Hepatic Encephalopathy
Hepatic Encephalopathy

Treatments

Diagnostic Test: neurophysiological tests, blood biomarkers.

Study type

Observational

Funder types

Other

Identifiers

NCT04058327
MHE study

Details and patient eligibility

About

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.

Full 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.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

252 participants in 2 patient groups

MHE group
Description:
Patients whose MHE test are positive
Treatment:
Diagnostic Test: neurophysiological tests, blood biomarkers.
no HE group
Description:
Patients whose MHE test are negative
Treatment:
Diagnostic Test: neurophysiological tests, blood biomarkers.

Trial contacts and locations

1

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Central trial contact

Qin Ning, MD., PhD.; Qiuyu Cheng, Bachelor

Data sourced from clinicaltrials.gov

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