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CompletedNCT04058327Updated Jun 17, 2024

A Study of MHE in Patients With Liver Diseases

An observational study in Hepatic Encephalopathy, Minimal Hepatic Encephalopathy and Overt Hepatic Encephalopathy, sponsored by Qin Ning. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-17.

Sponsored by Qin Ning · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
252
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Hepatic Encephalopathy

225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.

This study's enrollment of 252 is above the median of 100 across 58 observational studies indexed under Hepatic Encephalopathy.

Browse Hepatic Encephalopathy studies →

Lead sponsor

Qin Ning is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with cirrhosis, acute on chronic liver failure

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
252 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testneurophysiological tests, blood biomarkers.

    Let the patients do neuropsychological tests and detect blood biomarkers.

06

What researchers measure

Primary outcomes

  1. progression of 2-4 HE

    Incidence of HE progression (2/3/4 HE)

    Time frame: 30 days

  2. mortality in short, median and long term

    mortality in 30 days, 90 days, 1 year, 2 years, 3 years

    Time frame: 30 and 90 days, 1, 2, 3 years

07

Study locations

1 site
  • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04058327
Lead sponsor
Qin Ning
Responsible party
Qin Ning (Director of Department of Infectious Diseases, Tongji Hospital) — Sponsor-investigator
First posted
Aug 15, 2019
Start date
May 1, 2019
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022
Last update
Jun 17, 2024

Study contacts

Qin Ning, MD., PhD.
study chair · Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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