Hepatopulmonary SyndromeNCT03435406
Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China
An observational study of Hepatopulmonary Syndrome, run by Southwest Hospital, China at 1 site in China.
Trial summary
to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatopulmonary Syndrome
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2017to 1 Apr 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were selected with cirrhosis caused by HBV including Southwest Hospital, the first affiliated hospital of Chongqing Medical University, the People's hospital of Rongchang district and Qijiang District people's hospital
Who may be able to join
- Age: 18-80 years old;
- American association of anesthesiologists(ASA) score: I-III;
- Ability to comply with research programmes;
- Voluntary participation in the study;
- Has the history of HBV infection;
- No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)
Who cannot join
- Severe heart, lung, kidney disease coexisted;
- American association of anesthesiologists(ASA) score≥IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) <70%, or FEV1 / FVC <0.70;
- Mental state could not cooperate
- Absence of written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Southwest Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400038
Yi Bin, PhD, 0086-18502340072, tang123a123123@163.com
About this study
to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China
Read the detailed description
Hepatopulmonary syndrome (HPS) occurs in approximately 4%-29% of cirrhotic patients and influences mortality. China has 100 million Hepatitis B virus (HBV) carriers and Chronic HBV infection is well-recognized risk factor for cirrhosis.But little is known about the prevalence of HPS in cirrhosis patients caused by HBV in western China. The aim of this study was to investigate the HPS incidence, and the signs, symptoms, arterial blood gas, and BMP9 in the serum of the patients.
- Conditions
- Hepatopulmonary Syndrome
- Keywords
- Hepatitis B, Chronic, Cirrhosis, Hepatopulmonary Syndrome
- Medical subject headings
- Hepatopulmonary Syndrome, Hepatitis B, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cirrhosis with HPS | Diagnosed as HPS | |
| cirrhosis without HPS | Not Diagnosed as HPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
transthoracic contrast enhanced echocardiography (CEE)
through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline
Measured: During the operation
arterial blood gas
arterial blood gas analysis was performed through the radial artery.
Measured: During the operation
medical history
The medical history was collected through consultation.
Measured: During the operation
acropachy
acropachy was examined by inspection
Measured: During the operation
spider angioma
spider angioma was examined by inspection
Measured: During the operation
liver palms
liver palms was examined by inspection
Measured: During the operation
oxygen saturation
oxygen saturation was examined by pulse oximetry
Measured: During the operation
Secondary outcomes (2)
the content of bone morphogenetic protein (BMP9) in the patients with and without HPS
the content and expression of BMP9 were determined by immunohistochemistry.
Measured: 4 to 6 months after the study completion
micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS
the content and expression of BMP9 were determined by polymerase chain reaction (PCR)
Measured: 4 to 6 months after the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start27 Jul 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatopulmonary SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu KZ, Southwest Hospital, China
- Investigators
- Lu K Zhi, PhD, Study director, Department of Anesthesiology, Southwest Hospital Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435406
- Sponsor's protocol ID
- CEE-HBV
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China
- ClinicalTrials.gov ID
- NCT03435406
- Acronym / sponsor ID
- CEE-HBV
- Conditions
- Hepatopulmonary Syndrome
- Keywords
- Hepatitis B, Chronic, Cirrhosis, Hepatopulmonary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 19 Feb 2018 (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.
to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China
Detailed description
Hepatopulmonary syndrome (HPS) occurs in approximately 4%-29% of cirrhotic patients and influences mortality. China has 100 million Hepatitis B virus (HBV) carriers and Chronic HBV infection is well-recognized risk factor for cirrhosis.But little is known about the prevalence of HPS in cirrhosis patients caused by HBV in western China. The aim of this study was to investigate the HPS incidence, and the signs, symptoms, arterial blood gas, and BMP9 in the serum of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cirrhosis with HPS | – | –Diagnosed as HPS |
| cirrhosis without HPS | – | –Not Diagnosed as HPS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected with cirrhosis caused by HBV including Southwest Hospital, the first affiliated hospital of Chongqing Medical University, the People's hospital of Rongchang district and Qijiang District people's hospital
Key inclusion criteria (6 listed)
- Age: 18-80 years old;
- American association of anesthesiologists(ASA) score: I-III;
- Ability to comply with research programmes;
- Voluntary participation in the study;
- Has the history of HBV infection;
Key exclusion criteria (4 listed)
- Severe heart, lung, kidney disease coexisted;
- American association of anesthesiologists(ASA) score≥IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) <70%, or FEV1 / FVC <0.70;
- Mental state could not cooperate
- Absence of written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
transthoracic contrast enhanced echocardiography (CEE)
Time frame: During the operation
through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline
arterial blood gas
Time frame: During the operation
arterial blood gas analysis was performed through the radial artery.
medical history
Time frame: During the operation
The medical history was collected through consultation.
acropachy
Time frame: During the operation
acropachy was examined by inspection
spider angioma
Time frame: During the operation
spider angioma was examined by inspection
liver palms
Time frame: During the operation
liver palms was examined by inspection
oxygen saturation
Time frame: During the operation
oxygen saturation was examined by pulse oximetry
2 secondary outcomes
the content of bone morphogenetic protein (BMP9) in the patients with and without HPS
Time frame: 4 to 6 months after the study completion
micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS
Time frame: 4 to 6 months after the study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
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.
Lu K Zhi, PhD study director
Department of Anesthesiology, Southwest Hospital Third Military Medical University
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, run by Southwest Hospital, China 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 6 inclusion and 4 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 19 Feb 2018. 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?
Contact Yi Bin, PhD (0086-02368754197, tang123a123123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transthoracic contrast enhanced echocardiography (CEE) (time frame: During the operation). The study lists 7 primary outcomes in all. 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 19 Feb 2018.