Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-02 @ 2:15 AM
Study NCT ID:
NCT02051595
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2014-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ettorecrimi@gmail.com', 'phone': '617-697-2861', 'title': 'Dr. Ettore Crimi', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Vancomycin Concentrations', 'description': 'Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.\n\nVancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Circulating Vancomycin Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin Concentrations', 'description': 'Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.\n\nVancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'estimate (beta) from mixed model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.068', 'ciLowerLimit': '-0.098', 'ciUpperLimit': '-0.039', 'pValueComment': 'A priori threshold was set to p \\< 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.015', 'estimateComment': 'Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)', 'description': 'Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin Concentrations', 'description': 'Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.\n\nVancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vancomycin Concentrations', 'description': 'Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.\n\nVancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2014-01-29', 'resultsFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-23', 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating Vancomycin Concentration', 'timeFrame': 'Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)', 'description': 'Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart lung machine', 'blood pump', 'cardiac surgery', 'cardiopulmonary bypass', 'circulation'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin. During cardiac surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used and can lower the level of the antibiotic. The purpose of this study is to quantify the change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified ultrafiltration.', 'detailedDescription': 'Subjects having cardiac surgery in which they will be on a heart-lung machine and will receive the antibiotic vancomycin, will be able to participate.\n\nUp to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Participation will be complete once the cardiac surgery has been finished.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration\n* age greater than 18 years old\n* penicillin allergy or in-hospital stay greater than 24 hours\n* normal renal function\n* normal liver function\n* absence of clinical and laboratory signs of infection\n\nExclusion Criteria:\n\n* vancomycin allergy\n* pregnancy\n* impaired renal function\n* impaired liver function\n* morbid obesity\n* active infections\n* Jehovah's Witness"}, 'identificationModule': {'nctId': 'NCT02051595', 'briefTitle': 'The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery', 'orgStudyIdInfo': {'id': '201300857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vancomycin concentrations', 'description': 'Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.', 'interventionNames': ['Other: Vancomycin concentrations']}], 'interventions': [{'name': 'Vancomycin concentrations', 'type': 'OTHER', 'otherNames': ['pharmacodynamics', 'vancomycin monitoring', 'serum concentrations of vancomycin'], 'description': 'Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.', 'armGroupLabels': ['Vancomycin concentrations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Ettore Crimi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}