Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 11:19 AM
Study NCT ID:
NCT02314520
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2014-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Complications Associated With Central Venous Access in the NSICU: PICC vs CVC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002406', 'term': 'Catheterization, Peripheral'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jzacko@pennstatehealth.psu.edu', 'phone': '717-531-1279', 'title': 'Dr. J. Christopher Zacko', 'organization': 'Penn State Health Milton S. Hershey Medical Center Dept of Neurosurgery'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '19 Months', 'description': 'Definitions do not differ.', 'eventGroups': [{'id': 'EG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 13, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 9, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Deep venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Complications With Central Access Including Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'OG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.271', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 is the threshold for significance for this primary outcome.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 10 weeks', 'description': 'Aggregation of all complications associated with central access including insertion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Deep Venous Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'OG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 10 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Complications Related to Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'OG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of insertion until first confirmatory chest X-ray', 'description': 'Any complication of insertion including technical failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Central Line Associated Blood Stream Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'OG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 10 weeks', 'description': 'A Central access associated infection (CLABSI)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'FG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.\n\nperipherally inserted central catheter: Any complication associated with central access'}, {'id': 'BG001', 'title': 'Central Line', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.\n\ncentrally inserted central catheter: Central access not associated with any complication'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '18', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '15.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '80', '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': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glasgow Coma Scale (Total)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '10', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '10', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Glasgow Goma Scale (GCS) gives a description of level of consciousness. Patients are assigned a minimum of 1 and maximum of 6 units on a scale for motor skills, a minimum of 1 and maximum of 5 units on a scale for verbal skills, a minimum of 1 and maximum of 4 units on a scale for eye opening function. The total GCS is a simple sum of all of the units on a scale with a minimum of 3 and maximum of 15. Higher values indicate higher neurologic function.', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemiparesis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'title': 'stroke', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'subarachnoid hemorrhage', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'traumatic brain injury', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'intraparenchymal hematoma', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'myasthenia gravis', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'intraventricular hemorrhage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2014-11-26', 'resultsFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-21', 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Complications With Central Access Including Insertion', 'timeFrame': 'up to 10 weeks', 'description': 'Aggregation of all complications associated with central access including insertion'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Deep Venous Thrombosis', 'timeFrame': 'up to 10 weeks'}, {'measure': 'Number of Patients With Complications Related to Insertion', 'timeFrame': 'From the time of insertion until first confirmatory chest X-ray', 'description': 'Any complication of insertion including technical failure'}, {'measure': 'Number of Participants With a Central Line Associated Blood Stream Infection', 'timeFrame': 'up to 10 weeks', 'description': 'A Central access associated infection (CLABSI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['PICC', 'Central Venous Catheter', 'Central Line', 'Neuro ICU', 'Neuroscience ICU', 'CVC']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients admitted to the NSICU, who require central access for the treatment of their illness.\n\nExclusion Criteria:\n\n1. Current or recent (within 1 month) diagnosis of bacteremia\n2. Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis\n3. Existing central access\n4. Non-English speaking\n5. Requirement for emergent central access and unable to obtain consent in an emergency setting'}, 'identificationModule': {'nctId': 'NCT02314520', 'acronym': 'NSPVC', 'briefTitle': 'Complications Associated With Central Venous Access in the NSICU: PICC vs CVC', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Complications Associated With Central Venous Access in the NSICU: PICC vs CVC', 'orgStudyIdInfo': {'id': 'STUDY00000582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PICC', 'description': 'Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.', 'interventionNames': ['Device: peripherally inserted central catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CVC', 'description': 'Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.', 'interventionNames': ['Device: centrally inserted central catheter']}], 'interventions': [{'name': 'peripherally inserted central catheter', 'type': 'DEVICE', 'description': 'Any complication associated with central access', 'armGroupLabels': ['PICC']}, {'name': 'centrally inserted central catheter', 'type': 'DEVICE', 'description': 'Central access not associated with any complication', 'armGroupLabels': ['CVC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurosurgery', 'investigatorFullName': 'Chris Zacko', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}