Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT03523260
Status:
WITHDRAWN
Last Update Posted:
2021-05-10
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Never funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '1 month', 'description': '1 month complication rate of left internal jugular vein dialysis catheters'}], 'secondaryOutcomes': [{'measure': 'Catheter dysfunction', 'timeFrame': '1 months', 'description': '1 month complication rate of left internal jugular vein dialysis catheters'}, {'measure': 'Catheter dysfunction', 'timeFrame': '3 months', 'description': '3 months complication rate of left internal jugular vein dialysis catheters'}, {'measure': 'Catheter dysfunction', 'timeFrame': '6 months', 'description': '6 months complication rate of left internal jugular vein dialysis catheters'}, {'measure': 'Complication rate', 'timeFrame': '3 months', 'description': '3 months complication rate of left internal jugular vein dialysis catheters'}, {'measure': 'Complication rate', 'timeFrame': '6 months', 'description': '6 months complication rate of left internal jugular vein dialysis catheters'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['End Stage Renal Disease on Dialysis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.', 'detailedDescription': "The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide a written informed consent\n2. 19 years or older\n3. Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.\n4. Patent left internal jugular vein.\n5. Able to read and understand English.\n\nExclusion Criteria:\n\n1. Previous enrollment in this trial\n2. Patients unable or unwilling to provide informed consent\n3. Prisoners or incarcerated individuals\n4. Women who are pregnant\n5. Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated'}, 'identificationModule': {'nctId': 'NCT03523260', 'briefTitle': 'Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)', 'orgStudyIdInfo': {'id': 'IRB-130430002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tunneled dialysis Split-tip catheter', 'description': 'High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique', 'interventionNames': ['Device: Tunneled dialysis catheter placement.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tunneled dialysis Step-tip catheter', 'description': 'High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique', 'interventionNames': ['Device: Tunneled dialysis catheter placement.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tunneled dialysis Symmetric tip catheter', 'description': 'High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique', 'interventionNames': ['Device: Tunneled dialysis catheter placement.']}], 'interventions': [{'name': 'Tunneled dialysis catheter placement.', 'type': 'DEVICE', 'description': 'Placement of high-flow tunneled catheter for hemodialysis', 'armGroupLabels': ['Tunneled dialysis Split-tip catheter', 'Tunneled dialysis Step-tip catheter', 'Tunneled dialysis Symmetric tip catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Akabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Radiology', 'investigatorFullName': 'Husameddin M El Khudari', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}