Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT03435406
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020065', 'term': 'Hepatopulmonary Syndrome'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transthoracic contrast enhanced echocardiography (CEE)', 'timeFrame': 'During the operation', 'description': 'through the ultrasound to evaluate the imagine of cardiac cavity after intravenous injection of agitated saline'}, {'measure': 'arterial blood gas', 'timeFrame': 'During the operation', 'description': 'arterial blood gas analysis was performed through the radial artery.'}, {'measure': 'medical history', 'timeFrame': 'During the operation', 'description': 'The medical history was collected through consultation.'}, {'measure': 'acropachy', 'timeFrame': 'During the operation', 'description': 'acropachy was examined by inspection'}, {'measure': 'spider angioma', 'timeFrame': 'During the operation', 'description': 'spider angioma was examined by inspection'}, {'measure': 'liver palms', 'timeFrame': 'During the operation', 'description': 'liver palms was examined by inspection'}, {'measure': 'oxygen saturation', 'timeFrame': 'During the operation', 'description': 'oxygen saturation was examined by pulse oximetry'}], 'secondaryOutcomes': [{'measure': 'the content of bone morphogenetic protein (BMP9) in the patients with and without HPS', 'timeFrame': '4 to 6 months after the study completion', 'description': 'the content and expression of BMP9 were determined by immunohistochemistry.'}, {'measure': 'micro ribonucleic acid 144 (miR144), micro ribonucleic acid 200 (miR200) in the patients with and without HPS', 'timeFrame': '4 to 6 months after the study completion', 'description': 'the content and expression of BMP9 were determined by polymerase chain reaction (PCR)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B, Chronic', 'Cirrhosis', 'Hepatopulmonary Syndrome'], 'conditions': ['Hepatopulmonary Syndrome']}, 'descriptionModule': {'briefSummary': 'to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by Hepatitis B in western China', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-80 years old;\n2. American association of anesthesiologists(ASA) score: I-III;\n3. Ability to comply with research programmes;\n4. Voluntary participation in the study;\n5. Has the history of HBV infection;\n6. No primary cardiopulmonary disease (heart disease, emphysema, pneumonia, asthma, etc.)\n\nExclusion Criteria:\n\n1. Severe heart, lung, kidney disease coexisted;\n2. American association of anesthesiologists(ASA) scoreā„IV; forced expiratory volume at one second (FEV1) or forced vital capacity (FVC) \\<70%, or FEV1 / FVC \\<0.70;\n3. Mental state could not cooperate\n4. Absence of written informed consent.'}, 'identificationModule': {'nctId': 'NCT03435406', 'briefTitle': 'Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Investigation of the Prevalence of Hepatopulmonary Syndrome in Cirrhosis Patients Caused by Hepatitis B in Western China', 'orgStudyIdInfo': {'id': 'CEE-HBV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cirrhosis with HPS', 'description': 'Diagnosed as HPS'}, {'label': 'cirrhosis without HPS', 'description': 'Not Diagnosed as HPS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Bin, PhD', 'role': 'CONTACT', 'email': 'tang123a123123@163.com', 'phone': '0086-18502340072'}], 'facility': 'Department of Anesthesiology, Southwest Hospital Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yi Bin, PhD', 'role': 'CONTACT', 'email': 'tang123a123123@163.com', 'phone': '0086-02368754197'}, {'name': 'tang xi, md', 'role': 'CONTACT', 'email': '12923699@qq.com', 'phone': '0086-18623198332'}], 'overallOfficials': [{'name': 'Lu K Zhi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Southwest Hospital Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Institute of Anesthesiology, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China', 'investigatorFullName': 'Lu KZ', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}