Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT01642459
Status:
TERMINATED
Last Update Posted:
2015-05-20
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'The patients enrolled are limited.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of AVF aneurysm and stenosis.', 'timeFrame': '12 months', 'description': 'Compare the prevalence of AVF aneurysm and stenosis between two groups during 12 months.'}], 'secondaryOutcomes': [{'measure': 'Proportions of AVF dysfunction in different groups.', 'timeFrame': '12 months', 'description': 'Compare the proportions of AVF dysfunction between two groups during 12 months.'}, {'measure': 'The size of venous aneurysm.', 'timeFrame': '12 months', 'description': 'Measure the maximum size of venous aneurysm by using ultrasonography at month 12.'}, {'measure': 'Diameter of venous stenosis.', 'timeFrame': '12 months', 'description': 'Measure the minimum diameter of venous stenosis by ultrasonography at month 12.'}, {'measure': 'Percentages of unsuccessful cannulations.', 'timeFrame': '12 months', 'description': 'Unsuccessful cannulations include mis-cannulation, cannulation ease, hematoma, more than once cannulation at arterial site.'}, {'measure': 'Events of AVF obstruction.', 'timeFrame': '12 months', 'description': 'AVF obstruction and the following treatments as central venous catheters and interventions will be recorded and compared between two groups during 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arteriovenous fistula', 'hemodialysis', 'aneurysm', 'vascular stenosis', 'cannulation'], 'conditions': ['Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.', 'detailedDescription': 'Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MHD patients with autogenous AVF.\n* Newly setup AVF in 3 months.\n* Fore- or Upper arm AVF.\n* Flow of \\>800ml/min detected by using the ultrasound dilution technique.\n\nExclusion Criteria:\n\n* AVF after neoplasty.\n* Arteriovenous grafts.\n* Anticipated live time less than one year.\n* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.'}, 'identificationModule': {'nctId': 'NCT01642459', 'briefTitle': 'The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Outcomes of Arteriovenous Fistula (AVF) Cannulated From Different Direction in Maintenance Hemodialysis Patients.', 'orgStudyIdInfo': {'id': '2012-0107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Same direction cannulation', 'description': 'The inserted direction of arterial needle is same as the direction of blood flow.', 'interventionNames': ['Other: Same direction cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opposite direction cannulation', 'description': 'The inserted direction of arterial needle is opposite to the direction of blood flow.', 'interventionNames': ['Other: Opposite direction cannulation']}], 'interventions': [{'name': 'Same direction cannulation', 'type': 'OTHER', 'description': 'The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.', 'armGroupLabels': ['Same direction cannulation']}, {'name': 'Opposite direction cannulation', 'type': 'OTHER', 'description': 'The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.', 'armGroupLabels': ['Opposite direction cannulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friedship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Dongliang Zhang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Kidney Disease Faculty of Capital Medical University'}, {'name': 'Wenying Cui, Bachelor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nephrology Department of Beijing Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongliang Zhang, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associated professer', 'investigatorFullName': 'Dongliang Zhang, MD', 'investigatorAffiliation': 'Capital Medical University'}}}}