- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05932927
Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome
July 3, 2023 updated by: Sun Jie
Hepatopulmonary syndrome (HPS) has unknown pathogenesis, limited treatment and poor prognosis.
The onset of HPS is insidious and easy to be ignored.
Many liver diseases such as "cirrhosis and related complications" are the core characteristics of Beijing You 'an Hospital, but the clinical characteristics of HPS patients in the center are still unclear.
The investigators plan to make the diagnosis of HPS among chronic liver disease patients in the hospital according to the diagnostic criteria of HPS proposed in the Practice Guidelines of the International Society of Liver Transplantation in 2016, collect clinical data of HPS participants, evaluate the severity, analyze and summarize clinical characteristics, and conduct management and follow-up.
At the same time, The investigators collect blood samples for proteomics tests.
In order to improve the diagnosis and treatment level of HPS.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
At present, the mechanism of hepatopulmonary syndrome is not clear.
The researchers plan to use the extracted plasma for detection, protein extraction and quality control, and then proteolytic hydrolysis, computer detection, and bioinformatics analysis.
Study Type
Observational
Enrollment (Estimated)
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 Locations
-
-
-
Beijing, China, 100038
- Recruiting
- No.8, Xitoutiao, Youan Men Wai, Fengtai District
-
Contact:
- Jie Sun
- Phone Number: 15901412001
- Email: sunjie3010@126.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic liver disease admitted to You 'an Hospital.
Description
Inclusion Criteria:
- chronic hepatitis Agreed to venous blood collection
Exclusion Criteria:
- pneumonia, pulmonary vascular disease, interstitial pulmonary disease, COPD, bronchial asthma, lung cancer and other primary pulmonary diseases, acute upper gastrointestinal bleeding.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic liver disease with hepatopulmonary syndrome
Liver disease (usually cirrhosis with portal hypertension) ;Positive CE-TTE(Contrast enhanced contrast ultrasound);Abnormal arterial oxygenation: Alveolar-arterial oxygen gradient (AaO2) ≥ 15 mm Hg (>20 mm Hg if age > 64)
|
Proteomic sequencing, bioinformatics analysis,find abnormal indicators between two groups
|
|
Chronic liver disease without hepatopulmonary syndrome
Liver disease (usually cirrhosis with portal hypertension) ; Negative CE-TTE
|
Proteomic sequencing, bioinformatics analysis,find abnormal indicators between two groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proteomic results of participants
Time Frame: April 1,2024
|
Qualitative and quantitative analysis of proteome
|
April 1,2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 9, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-096
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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