A Study of MHE in Patients With Liver Diseases

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058327
• Other study ID #: MHE study
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2019
• Source: Tongji Hospital
• Contact: Qin Ning, MD., PhD.
• Phone: +8602783662391
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• cirrhosis

• acute on chronic liver failure

• severe liver diseases

Exclusion Criteria:

• liver cancer

• other malignancy

• poor eyesight

• uncooperative

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Brain Diseases
• Cirrhosis, Liver
• End Stage Liver Disease
• Fibrosis
• Hepatic Encephalopathy
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Diseases
• Liver Failure
• Minimal Hepatic Encephalopathy

Intervention

Diagnostic Test:
• blood ammonia test, neurophysiological/psychological tests, blood markers.
Let the patients do neuropsychological/psychological tests and use blood test for ammonia and blood markers.

Drug:
• HE drug treatments in clinical real world
record the HE drug treatments in clinical real world if doctors use them

Locations

Country	Name	City	State
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression of HE	Incidence of HE progression (none HE, 1 HE, 2/3/4 HE)	1 year
Primary	mortality at 90 days	mortality rate at 90 days	90 days
Secondary	liver disease progression	Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)	1 year