- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058327
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
Status
Unknown
Conditions
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
- Name: Qin Ning, MD., PhD.
- Phone Number: +8602783662391
- Email: qning@vip.sina.com
Study Contact Backup
- Name: Qiuyu Cheng, Bachelor
- Phone Number: +8618202761557
- Email: 1226271272@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Qin Ning, PHD,MD
- Phone Number: +8602783662391
- Email: qning@vip.sina.com
-
Principal Investigator:
- Qin Ning, PHD,MD
-
Sub-Investigator:
- Tao Chen, PHD,MD
-
Contact:
- Qiuyu Cheng, Bachelor
- Phone Number: +8618202761557
- Email: 1226271272@qq.com
-
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Liver Failure, Acute
- Brain Diseases, Metabolic
- Liver Diseases
- End Stage Liver Disease
- Fibrosis
- Liver Failure
- Hepatic Insufficiency
- Acute-On-Chronic Liver Failure
- Liver Cirrhosis
- Hepatic Encephalopathy
- Brain Diseases
Other Study ID Numbers
- MHE study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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