Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03485833
Status:
UNKNOWN
Last Update Posted:
2018-04-02
First Post:
2018-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-02-01', 'releaseDate': '2018-08-10'}], 'estimatedResultsFirstSubmitDate': '2018-08-10'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'responders', 'timeFrame': 'within 1 minute after volume expansion', 'description': 'responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid'}], 'secondaryOutcomes': [{'measure': 'nonresponders', 'timeFrame': 'within 1 minute after volume expansion', 'description': 'nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['end-expiratory occlusion test', 'end-inspiratory occlusion test', 'transesophageal echocardiography', 'passive legs raising', 'fluid challenge'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.', 'detailedDescription': 'Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac surgical patients\n* hypotension after induction of anesthesia\n* required volume expansion by clinical judgement of the anesthesiologist\n\nExclusion Criteria:\n\n* younger than 18 years\n* severe valve regurgitation or systolic dysfunction of the right ventricle\n* contraindication of the transesophageal echocardiography examination\n* cardiac arrhythmia\n* left ventricular ejection fraction less than 30% before surgery'}, 'identificationModule': {'nctId': 'NCT03485833', 'acronym': 'EEOFR', 'briefTitle': 'End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients', 'orgStudyIdInfo': {'id': 'EEOFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EEO and EIO test', 'description': 'velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.', 'interventionNames': ['Diagnostic Test: EEO and EIO test']}], 'interventions': [{'name': 'EEO and EIO test', 'type': 'DIAGNOSTIC_TEST', 'description': 'velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test', 'armGroupLabels': ['EEO and EIO test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-wei Tu, PhD', 'role': 'CONTACT'}], 'facility': 'Zhongshan hospital, Fudan university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhe Luo, PhD', 'role': 'CONTACT', 'email': 'luo.zhe@zs-hospital.sh.cn', 'phone': '021-64041990', 'phoneExt': '3659'}], 'overallOfficials': [{'name': 'Guo-wei Tu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-10', 'type': 'RELEASE'}, {'date': '2019-02-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanghai Zhongshan Hospital'}}}}