Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-03 @ 7:56 PM
Study NCT ID:
NCT05166759
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Right cardiac functionof Pulmonary Hypertension Secondary to ARDS in the Highland', 'timeFrame': '20/11/2021-20/12/2022'}], 'primaryOutcomes': [{'measure': 'Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland', 'timeFrame': '20/11/2021-20/12/2022'}, {'measure': 'ICU mortality ICU mortality', 'timeFrame': '20/11/2021-20/12/2022', 'description': 'Mortality during treatment in ICU'}, {'measure': '28-days mortality rate', 'timeFrame': '20/11/2021-20/12/2022', 'description': 'Mortality at 28 days of hospitalization'}], 'secondaryOutcomes': [{'measure': 'Ventilator time', 'timeFrame': '20/11/2021-20/12/2022', 'description': 'Ventilator time in ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': '20/11/2021-20/12/2022', 'description': 'Total length of stay in hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '37524522', 'type': 'DERIVED', 'citation': 'Zhu P, Zhu J, Tong S, She X, Qi Z, Xu Q, Shi Z, Si L, Hou M, Gan G, Pan C. Clinical characteristics of patients with a risk of pulmonary artery hypertension secondary to ARDS in a high-altitude area. BMJ Open Respir Res. 2023 Jul;10(1):e001475. doi: 10.1136/bmjresp-2022-001475.'}]}, 'descriptionModule': {'briefSummary': 'The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\n18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours\n\n\\-\n\nExclusion Criteria:\n\nPatients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05166759', 'briefTitle': 'Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS', 'orgStudyIdInfo': {'id': 'ARDS in the highland'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Doppler ultrasound', 'type': 'DEVICE', 'description': 'Pulmonary artery pressure and right heart function will be assessed using Doppler ultrasound'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Pan, MD', 'role': 'CONTACT', 'email': 'panchun1982@gmail.com', 'phone': '13814009925'}], 'facility': 'Affiliated Hospital of QingHai University', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}], 'centralContacts': [{'name': 'Chun Pan, MD', 'role': 'CONTACT', 'email': 'panchun1982@gmail.com', 'phone': '13814009925'}, {'name': 'Peng Zhu', 'role': 'CONTACT', 'email': 'sqzhupeng@163.com', 'phone': '18625195060'}], 'overallOfficials': [{'name': 'Chun Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qinghai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qinghai University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chun Pan', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}