Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-26 @ 4:48 AM
Study NCT ID:
NCT03190668
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Skeletal Muscle and Adipose Tissue Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cseubert@anest.ufl.edu', 'phone': '352-273-8960', 'title': 'Christoph Seubert, MD', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.\n\nBolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.\n\nContinuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Unbound Cefazolin Concentration in Skeletal Muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.\n\nBolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}, {'id': 'OG001', 'title': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.\n\nContinuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}], 'classes': [{'categories': [{'measurements': [{'value': '3.22', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': '7.62'}, {'value': '5.84', 'groupId': 'OG001', 'lowerLimit': '3.01', 'upperLimit': '11.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Changes from baseline (pre-op) up to end of surgical procedure', 'description': 'First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle', 'unitOfMeasure': 'µg/ml/kg', 'dispersionType': '75% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Unbound Cefazolin in Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.\n\nBolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}, {'id': 'OG001', 'title': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.\n\nContinuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}], 'classes': [{'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '8.24'}, {'value': '6.13', 'groupId': 'OG001', 'lowerLimit': '3.20', 'upperLimit': '11.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Changes from baseline (pre-op) up to end of surgical procedure', 'description': 'First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue', 'unitOfMeasure': 'µg/ml/kg', 'dispersionType': '75% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.\n\nBolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}, {'id': 'FG001', 'title': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.\n\nContinuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.\n\nBolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}, {'id': 'BG001', 'title': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.\n\nContinuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip\n\nParaspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle\n\nSubcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '17'}, {'value': '12.8', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '15'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One subject was withdrawn from each group and not included in the analysis due to insufficient data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-27', 'size': 285813, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-20T09:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2017-06-15', 'resultsFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-22', 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unbound Cefazolin Concentration in Skeletal Muscle', 'timeFrame': 'Changes from baseline (pre-op) up to end of surgical procedure', 'description': 'First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle'}, {'measure': 'Unbound Cefazolin in Adipose Tissue', 'timeFrame': 'Changes from baseline (pre-op) up to end of surgical procedure', 'description': 'First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tissue microdialysis', 'spinal fusion', 'surgical site infection'], 'conditions': ['Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.', 'detailedDescription': 'Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic scoliosis\n* Planned posterior spinal fusion surgery (PSFS)\n* Age: 12-20 years old\n* American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels\n* No known allergy to cefazolin\n\nExclusion Criteria:\n\n* Known allergy to cefazolin\n* Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle\n* Known renal or hepatic insufficiency or failure'}, 'identificationModule': {'nctId': 'NCT03190668', 'briefTitle': 'Skeletal Muscle and Adipose Tissue Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery', 'orgStudyIdInfo': {'id': 'IRB201701129 -A'}, 'secondaryIdInfos': [{'id': 'OCR18899', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'First Regimen Group', 'description': 'The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.', 'interventionNames': ['Drug: Bolus dose of Cefazolin', 'Device: Paraspinal muscle microdialysis catheters', 'Device: Subcutaneous microdialysis catheters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second Regimen Group', 'description': 'The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.', 'interventionNames': ['Drug: Continuous Cefazolin drip', 'Device: Paraspinal muscle microdialysis catheters', 'Device: Subcutaneous microdialysis catheters']}], 'interventions': [{'name': 'Bolus dose of Cefazolin', 'type': 'DRUG', 'otherNames': ['Standard mode of prophylactic cefazolin administration'], 'description': 'Mode of Cefazolin administration will be a intermittent bolus', 'armGroupLabels': ['First Regimen Group']}, {'name': 'Continuous Cefazolin drip', 'type': 'DRUG', 'otherNames': ['Continuous infusion of prophylactic cefazolin'], 'description': 'Mode of Cefazolin administration will be a continuous drip', 'armGroupLabels': ['Second Regimen Group']}, {'name': 'Paraspinal muscle microdialysis catheters', 'type': 'DEVICE', 'otherNames': ['Paraspinal muscle dialysate sample'], 'description': 'Two dialysis probes will be inserted into a paraspinal muscle', 'armGroupLabels': ['First Regimen Group', 'Second Regimen Group']}, {'name': 'Subcutaneous microdialysis catheters', 'type': 'DEVICE', 'otherNames': ['Subcutaneous dialysate sample'], 'description': 'Two dialysis probes will be inserted into a paraspinal subcutaneous region', 'armGroupLabels': ['First Regimen Group', 'Second Regimen Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Christoph Seubert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}