Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 3:30 PM
Study NCT ID:
NCT01103895
Status:
TERMINATED
Last Update Posted:
2016-05-27
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output after cardiopulmonary bypass', 'timeFrame': 'Less than 10 minutes', 'description': 'Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.'}], 'secondaryOutcomes': [{'measure': 'Cardiac output before cardiopulmonary bypass', 'timeFrame': 'Less than 10 minutes', 'description': "Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac output', 'cardiopulmonary bypass', 'ultrasound dilution'], 'conditions': ['Cardiac Output']}, 'descriptionModule': {'briefSummary': 'Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 21 years\n* Patients undergoing surgery involving cardiopulmonary bypass\n* Patients instrumented with a thermodilution catheter\n\nExclusion Criteria:\n\n* Patients aged \\< 21 years\n* Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)'}, 'identificationModule': {'nctId': 'NCT01103895', 'briefTitle': 'Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transonic Systems Inc.'}, 'officialTitle': 'Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'TSI-C-HCE101-4A-H'}, 'secondaryIdInfos': [{'id': '2R44HL082022-02', 'link': 'https://reporter.nih.gov/quickSearch/2R44HL082022-02', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14905', 'city': 'Elmira', 'state': 'New York', 'country': 'United States', 'facility': 'Arnot Ogden Medical Center', 'geoPoint': {'lat': 42.0898, 'lon': -76.80773}}], 'overallOfficials': [{'name': 'Nikolai Krivitski, PhD, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Transonic Systems Inc.'}, {'name': 'Edward P Nast, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arnot Ogden Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transonic Systems Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}