Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-01 @ 9:37 PM
Study NCT ID:
NCT04098159
Status:
UNKNOWN
Last Update Posted:
2019-09-24
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018616', 'term': 'Ultrasonography, Doppler, Duplex'}, {'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'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': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-21', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number, type and technical success rate for elective interventions', 'timeFrame': 'within one year of creation of the VA'}], 'secondaryOutcomes': [{'measure': 'secondary patency rate of the Arteriovenous Access after elective intervention', 'timeFrame': 'within one year of creation of the VA'}, {'measure': 'number , type of complication that resulted from elective interventions', 'timeFrame': 'within one year of creation of the VA'}, {'measure': 'primary patency rate of newly created Arteriovenous Access in assiut governorate', 'timeFrame': 'within one year of creation of the VA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Access Failure']}, 'referencesModule': {'references': [{'pmid': '10584659', 'type': 'BACKGROUND', 'citation': 'Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. doi: 10.1016/s1051-0443(99)70252-6. No abstract available.'}, {'pmid': '21906166', 'type': 'BACKGROUND', 'citation': 'Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE; North American Vascular Access Consortium. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011 Sep-Oct;24(5):515-24. doi: 10.1111/j.1525-139X.2011.00969.x. Epub 2011 Sep 9.'}, {'pmid': '11904577', 'type': 'BACKGROUND', 'citation': 'National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.'}, {'pmid': '8172208', 'type': 'BACKGROUND', 'citation': 'Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. doi: 10.1016/s0272-6386(12)70276-7.'}, {'pmid': '17507428', 'type': 'BACKGROUND', 'citation': 'Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.'}, {'pmid': '10965064', 'type': 'BACKGROUND', 'citation': 'Besarab A. Advances in end-stage renal diseases 2000. Access monitoring methods. Blood Purif. 2000;18(4):255-9. doi: 10.1159/000014445. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Types of VA include arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). A vascular access is liable to early or late complications, and ultimately access failure. A meta-analysis showed that a 17% mean early access failure However recent studies have shown higher failure rates of up to 46%, with one year patencies between 52% to 83% (3). Low VA flow, thrombosis and loss of patency may result in under-dialysis that leads to increased morbidity, mortality and healthcare expenditure (4). In the majority of VAs, stenoses develop over variable intervals causing VA thrombosis and failure (5). If early detected and corrected, VA function and patency can be preserved and under-dialysis can be minimized or avoided. The aim of this study is to find out the role of periodic surveillance of VA in the detection of VA dysfunction and correctable lesions that may necessitate pre-emptive interventions to maintain VA patency and prevent VA loss'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ESRD Patients have functioning or failing VAs (AVFs or AVGs).\n\nExclusion Criteria:\n\n* ESRD patients have infected or failed VAs .\n* patientrefusal .'}, 'identificationModule': {'nctId': 'NCT04098159', 'briefTitle': 'Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access', 'orgStudyIdInfo': {'id': 'Surveillance of an A-V access'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESRD Patients have functioning or failing VAs (AVFs or AVGs).', 'interventionNames': ['Device: duplex ultrasound']}], 'interventions': [{'name': 'duplex ultrasound', 'type': 'DEVICE', 'otherNames': ['diagnostic venography', 'angioplasty', 'surgery'], 'description': 'regular duplex follow up every three months with subsequent intervention either diagnostic venography , angioplasty or surgery according to the type of the lesion', 'armGroupLabels': ['ESRD Patients have functioning or failing VAs (AVFs or AVGs).']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed m rashed, resident', 'role': 'CONTACT', 'email': 'ahmedrashed9933@gmail.com', 'phone': '00201064252719'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of vascular surgery', 'investigatorFullName': 'Ahmed Mohammed Rashed', 'investigatorAffiliation': 'Assiut University'}}}}