Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-01 @ 12:58 PM
Study NCT ID:
NCT01988766
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Thrombosis', 'timeFrame': '15 months', 'description': 'To calculate the incidence of deep venous thrombosis from PICC lines in patients'}], 'secondaryOutcomes': [{'measure': 'Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access', 'timeFrame': '15 months', 'description': 'To evaluate if factors, known to be associated with thrombosis and atherosclerosis, are associated with the risk of thrombosis from PICC or IJ access. These factors include: renal failure, diabetes, hypertension, cancer, transplant, gender, age or the indication for the access, including antibiotics or chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thrombosis', 'Central Venosis Catheter', 'Renal Disease', 'Vascular Access'], 'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.', 'detailedDescription': 'In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who had a PICC line placed at the University of Chicago by the procedure service between September 1, 2010 and December 31, 2011', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011\n\nExclusion Criteria:\n\n* subjects under the age of 18'}, 'identificationModule': {'nctId': 'NCT01988766', 'briefTitle': 'Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement', 'orgStudyIdInfo': {'id': 'IRB12-1889'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thrombosis', 'description': 'incidence of thrombosis in subjects who had PICC line placement'}, {'label': 'No Thrombosis', 'description': 'no incidence of thrombosis in subjects who had PICC line placement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mary Hammes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}