Clinical trial NCT04058327: A Study of MHE in Patients With Liver Diseases
Official title: A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhosis, acute on chronic liver failure

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression of 2-4 HE
timeFrame: 30 days
measure: mortality in short, median and long term
timeFrame: 30 and 90 days, 1, 2, 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
name: Qin Ning, MD., PhD.
role: STUDY_CHAIR
References: