Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-04-07 @ 2:59 PM
Study NCT ID:
NCT02880761
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011677', 'term': 'Punctures'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhangdongliang@pkuih.edu.cn', 'phone': '+861069006549', 'title': 'Director of Continuous Quality Improvement Experts Congress of Changping District', 'phoneExt': '1069006789', 'organization': 'Continuous Quality Improvement Experts Congress of Changping District'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF", 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 2, 'seriousNumAtRisk': 103, 'deathsNumAffected': 6, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 1, 'seriousNumAtRisk': 106, 'deathsNumAffected': 8, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'acute myocardial infarction', 'notes': 'Newly happened acute myocardial infarction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Fistula Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after surgery', 'description': 'The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Life Time of AVF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '19.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Equal to or larger than 2 years', 'description': 'The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).', 'unitOfMeasure': 'month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Value of Urea Clearance Index During 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'spread': '.28', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'As a parameter of hemodialysis adequacy, urea clearance index (Kt/V) will be detected very month. The Kt/V should be larger than 1.2 , which were regarded as being adequate in the hemodialysis session. This parameter will be tested every month and the mean value were be calculated according to the records during 24 months. Those who with Kt/V less than 1.2 for 3 times would be defined as the patient with unfunctional AVF. The values of Kt/V in unfunctional AVF patients would not be used in statistic analysis.', 'unitOfMeasure': 'Kt/V', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "Patients with native arterovenous fistula (AVF) will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.\n\nAssessment guiding surgery and puncture for AVF: Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF"}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Han', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height(cm)', 'classes': [{'categories': [{'measurements': [{'value': '167.3', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '167.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '167.3', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight(Kg)', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-20', 'size': 303467, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-11T09:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2016-08-17', 'resultsFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-11', 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Value of Urea Clearance Index During 24 Months', 'timeFrame': '2 years', 'description': 'As a parameter of hemodialysis adequacy, urea clearance index (Kt/V) will be detected very month. The Kt/V should be larger than 1.2 , which were regarded as being adequate in the hemodialysis session. This parameter will be tested every month and the mean value were be calculated according to the records during 24 months. Those who with Kt/V less than 1.2 for 3 times would be defined as the patient with unfunctional AVF. The values of Kt/V in unfunctional AVF patients would not be used in statistic analysis.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Fistula Failure', 'timeFrame': '3 months after surgery', 'description': 'The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.'}], 'secondaryOutcomes': [{'measure': 'Life Time of AVF', 'timeFrame': 'Equal to or larger than 2 years', 'description': 'The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'chronic renal failure', 'arteriovenous fistulae'], 'conditions': ['Arteriovenous Fistulae']}, 'descriptionModule': {'briefSummary': 'A cohort including more than 100 maintenance hemodialysis patients will be followed up according to a certain Following-up System of Native Arteriovenous Fistulae (AVF) prospectively. The assessment results of the Following-up System of AVF help the physicians make decisions of AVF surgery and puncture methods. The results of this study would identify the effect of the system on survival of AVF. Other 100 hemodialysis patients from other centers will be treated by routine protocol and compared to the experiment goup.', 'detailedDescription': 'The Following-up System of AVF includes 3 stages. In the 1st stage, before AVF surgery operation, the contents of Following-up System of AVF include history, physical exam, ultrasonography detection. The assesment results will guide the methods of the AVF surgery operation. In the 2nd stage, before AVF puncture firstly and 3 months after AVF operation, the contents of Following-up System of AVF include physical exam and ultrasonography detection. The results will help the nurses and doctors make a decision of the method of AVF puncture. In the 3rd stage, during the following 2 years after AVF puncture successfully, the contents include physical exam and ultrasonography detection regularly. The adequacy of hemodialysis by using AVF will be assessed by urea clearance index (Kt/V).\n\nThe data of patients in other hemodialysis centers will be recorded and compared to the patients in experiment group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maintenance hemodialysis patients using AVF;\n* Ages 18-70 years old;\n* Agreement with frequent following-up.\n\nExclusion Criteria:\n\n* Younger than 18 years or elder than 70 years;\n* Cachexia;\n* Acute renal failure;\n* Exceptive life time less than 6 months;\n* Pregnant or planning pregnant;\n* Waiting for renal transplantation or transferring to peritoneal dialysis.'}, 'identificationModule': {'nctId': 'NCT02880761', 'briefTitle': 'Cohort Study on A Following-up System of Native Arteriovenous Fistulae', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Cohort Study on A Following-up System of Native Arteriovenous Fistulae in Chinese Patients Treated by Maintenance Hemodialysis', 'orgStudyIdInfo': {'id': '2016-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Patients with AVF will be followed up by a preset following-up system. Interventions would be administered according to the assessment for AVF, which including the surgery and puncture of AVF. For AVF surgery, a certain vein would be used in the operation according to the assessment results. For AVF puncture, the methods, such as 'button hole', 'rope ladder', dwelling needle, would be selected prospectively according to the assessment results.", 'interventionNames': ['Procedure: Assessment guiding surgery and puncture for AVF']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in other hemodialysis centers who are treated by routine protocal would be enrolled into control group. Their clinical data would be collected and compared with intervention group.'}], 'interventions': [{'name': 'Assessment guiding surgery and puncture for AVF', 'type': 'PROCEDURE', 'description': 'Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University International Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Dongliang Zhang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated director of blood purification center', 'investigatorFullName': 'Dongliang Zhang, MD', 'investigatorAffiliation': 'Peking University International Hospital'}}}}