Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-20 @ 7:09 AM
Study NCT ID:
NCT02419404
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-11', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiac output', 'timeFrame': 'First five hours after surgery', 'description': 'Change in cardiac output after intravenous fluids are given'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypovolemia']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.', 'detailedDescription': 'Total to expected enrollment: 70'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having cardiac surgery who have a pulmonary artery catheter', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TCV-PO post-operative patients with PA catheters\n* Must be 18 years of age and older\n\nExclusion Criteria:\n\n* History of Pulmonary Hypertension'}, 'identificationModule': {'nctId': 'NCT02419404', 'briefTitle': 'Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU', 'orgStudyIdInfo': {'id': '16712'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients having cardiac surgery', 'description': 'Patients having cardiac surgery who have a pulmonary artery catheter will be eligible for inclusion in this study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'ROBERT H THIELE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Anesthesiology', 'investigatorFullName': 'Robert Thiele, MD', 'investigatorAffiliation': 'University of Virginia'}}}}