Hepatopulmonary Syndrome (HPS)NCT05932927
Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome
An observational study of Hepatopulmonary Syndrome (HPS), run by Sun Jie at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatopulmonary Syndrome (HPS)
- What is being tested?
- Proteomic sequencing
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Jun 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic liver disease admitted to You 'an Hospital.
Who may be able to join
- chronic hepatitis Agreed to venous blood collection
Who cannot join
- pneumonia, pulmonary vascular disease, interstitial pulmonary disease, COPD, bronchial asthma, lung cancer and other primary pulmonary diseases, acute upper gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.8, Xitoutiao, Youan Men Wai, Fengtai District
Beijing, 100038
Jie Sun, 15901412001, sunjie3010@126.com
About this study
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.
Read the 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.
- Conditions
- Hepatopulmonary Syndrome (HPS)
- Being tested
- Proteomic sequencing
- Medical subject headings
- Hepatopulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic sequencingBiological
Proteomic sequencing, bioinformatics analysis，find abnormal indicators between two groups
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Proteomic sequencing | |
| Chronic liver disease without hepatopulmonary syndrome | Liver disease (usually cirrhosis with portal hypertension) ； Negative CE-TTE Receives: Biological: Proteomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic results of participants
Qualitative and quantitative analysis of proteome
Measured: April 1,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopulmonary Syndrome (HPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sun Jie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Jie, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932927
- Sponsor's protocol ID
- 2022-096
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome
- ClinicalTrials.gov ID
- NCT05932927
- Acronym / sponsor ID
- 2022-096
- Conditions
- Hepatopulmonary Syndrome (HPS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun JieUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease with hepatopulmonary syndrome | – | Biological: Proteomic sequencingLiver 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) |
| Chronic liver disease without hepatopulmonary syndrome | – | Biological: Proteomic sequencingLiver disease (usually cirrhosis with portal hypertension) ； Negative CE-TTE |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease admitted to You 'an Hospital.
Key inclusion criteria (1 listed)
- chronic hepatitis Agreed to venous blood collection
Key exclusion criteria (1 listed)
- pneumonia, pulmonary vascular disease, interstitial pulmonary disease, COPD, bronchial asthma, lung cancer and other primary pulmonary diseases, acute upper gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic sequencingProteomic sequencing, bioinformatics analysis，find abnormal indicators between two groups | Biological | Chronic liver disease with hepatopulmonary syndrome, Chronic liver disease without hepatopulmonary syndrome |
Primary outcome
Proteomic results of participants
Time frame: April 1,2024
Qualitative and quantitative analysis of proteome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatopulmonary Syndrome (HPS), run by Sun Jie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic results of participants (time frame: April 1,2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.