Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-09 @ 8:56 PM
Study NCT ID:
NCT03179033
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responsiveness to passive leg raising in patients early after LVAD implantation', 'timeFrame': '5 minutes', 'description': 'Change in LVAD flow due to passive leg raising'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LVAD', 'Passive leg raising'], 'conditions': ['Artificial Heart Device User']}, 'descriptionModule': {'briefSummary': 'Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients with end-stage heart failure. Optimal fluid management is essential for adequate postoperative treatment. It is important to identify which patients will benefit from fluid administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid responsiveness in patients with heart failure by inducing a transient increase in cardiac preload. Objective: To investigate the role of PLR on the management of patients following LVAD implantation in the postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure candidate for assist device implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after VAD implantation\n\nExclusion Criteria:\n\n* Age under 18'}, 'identificationModule': {'nctId': 'NCT03179033', 'briefTitle': 'Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SHEBA-16-3259-ER-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}