Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02725151
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2016-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Heart Failure Monitoring Via Inferior Vena Cava Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2016-03-20', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vena cava inferior diameter change end of each 500cc urination', 'timeFrame': 'Maximum 3 hours'}], 'secondaryOutcomes': [{'measure': 'Vena cava inferior diameter change with classic treatment at each hour', 'timeFrame': 'Maximum 3 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inferior vena cava ultrasound', 'acute', 'heart failure', 'management', 'decompensation'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32189575', 'type': 'DERIVED', 'citation': 'Yamanoglu A, Celebi Yamanoglu NG, Ozturk S, Cakmak S, Akay S, Akyol PY, Sogut O. The value of the inferior vena cava ultrasound in the decision to hospitalise in patients with acute decompensated heart failure; the best sonographic measurement method? Acta Cardiol. 2021 May;76(3):245-257. doi: 10.1080/00015385.2020.1740422. Epub 2020 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. And investigators will calculation correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers will not interfere to standard recommended treatment protocol, researchers will correlated the urine amount and changed vital signs with therapy with Vena cava inferior diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients constitute the study population that was admitted to emergency department with complaint of dyspnea.These patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 18 years of age) of both sexes)\n* Non-trauma patients\n* Non- pregnant patients\n* All patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload\n\nExclusion Criteria:\n\n* Cardiac tamponade\n* Aortic dissection\n* Patients who had suffered cardiopulmonary arrest or been intubated'}, 'identificationModule': {'nctId': 'NCT02725151', 'briefTitle': 'Acute Heart Failure Monitoring Via Inferior Vena Cava Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Haseki Training and Research Hospital'}, 'officialTitle': 'The Role of Inferior Vena Cava in Emergency Treatment of Acute Decompensated Heart Failure and Deciding Hospitalization', 'orgStudyIdInfo': {'id': '231'}}, 'contactsLocationsModule': {'locations': [{'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Adnan Yamanoğlu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Adnan Yamanoğlu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haseki Training and Research Hospital, Emergency Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Already in the nearest congress will be shared as an oral presentation or poster'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haseki Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Medicine Specialist', 'investigatorFullName': 'Adnan Yamanoğlu', 'investigatorAffiliation': 'Haseki Training and Research Hospital'}}}}