A Study of MHE in Patients With Liver Diseases

August 13, 2019 updated by: Qin Ning

A Study on Early Diagnosis and Treatments of Minimal Hepatic Encephalopathy(MHE) in Patients With Liver Diseases

The investigators analyze the diagnostic efficacy of blood ammonia, neurophysiological/psychological tests and blood markers on MHE; to see the progression of HE under the condition of the drugs intervention and no drugs intervention in clinical real world.

Study Overview

Detailed Description

In China, hepatic encephalopathy (HE) is a common complication and one of the most serious manifestations of liver disease, not only increasing the risks of death, but also seriously affecting the lives of the patients and their caregivers. CHE includes the 1st stage of HE and minimal encephalopathy (MHE). It has indicated in a study that the mortality rates of covert hepatic encephalopathy (CHE) and overt hepatic encephalopathy (OHE) were both high (21% and 21.8% respectively). At present, CHE, especially MHE, is not easy to diagnose in daily clinical work. This study aims to early diagnose MHE and find suitable treatment to benefit patients. The investigators analyze the diagnostic efficacy of blood ammonia, neurophysiological/psychological tests and blood markers on MHE; to see the progression of HE under the condition of the drugs intervention and no drugs intervention in clinical real world.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Qin Ning, PHD,MD
        • Sub-Investigator:
          • Tao Chen, PHD,MD
        • Contact:
        • Sub-Investigator:
          • Qiuyu Cheng, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with cirrhosis, acute on chronic liver failure or severe liver diseases

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • liver cancer
  • other malignancy
  • poor eyesight
  • uncooperative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MHE group
Patients whose MHE test are positive
Let the patients do neuropsychological/psychological tests and use blood test for ammonia and blood markers.
record the HE drug treatments in clinical real world if doctors use them
no HE group
Patients whose MHE test are negative
Let the patients do neuropsychological/psychological tests and use blood test for ammonia and blood markers.
overt HE group
2/3/4 HE patients
Let the patients do neuropsychological/psychological tests and use blood test for ammonia and blood markers.
record the HE drug treatments in clinical real world if doctors use them

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression of HE
Time Frame: 1 year
Incidence of HE progression (none HE, 1 HE, 2/3/4 HE)
1 year
mortality at 90 days
Time Frame: 90 days
mortality rate at 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver disease progression
Time Frame: 1 year
Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Qin Ning, MD., PhD., Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

August 11, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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