Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-02 @ 12:49 PM
Study NCT ID:
NCT02747966
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to access the chang of the fistula blood flow in HD patients using Ultrasound Dilution method', 'timeFrame': 'Change of the fistula blood flow from baseline to 6 months'}], 'secondaryOutcomes': [{'measure': 'Changes of the Cardiac Index (CI) during the course of hemodialysis therapy', 'timeFrame': 'from baseline to 6 months'}, {'measure': 'Changes of the Oxygen delivery ( Adequacy of hemoglobin level to Epoetin) during the course of hemodialysis therapy', 'timeFrame': 'from baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['access flow', 'access recirculation', 'cardiac output', 'cardiac index', 'hemodialysis'], 'conditions': ['Complication of Hemodialysis']}, 'descriptionModule': {'briefSummary': 'A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.', 'detailedDescription': 'All patients recruited who met the inclusion criteria were investigated access flow, access recirculation and cardiac function(including cardiac output,cardiac index,central blood volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session). The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible participants are recruited according the inclusion and exclusion criteria.Their basis data are documented and the central hemodynamic condition are assess cross-sectionally and longitudinally.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergo HD with native AVF\n* AF of AVF between 300ml/min and 1800ml/min\n\nExclusion Criteria:\n\n* Patients whose AVF developed Access Recirculation (AR) which cannot be resolved at the time of measurement\n* Patients developed access or systemic infection during the study period'}, 'identificationModule': {'nctId': 'NCT02747966', 'briefTitle': 'The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of Access Flow ,Access Recirculation of Arteriovenous Fistula and the Relationship With Cardiac Function', 'orgStudyIdInfo': {'id': 'SYSU-HD02'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The 1st Affiliated Hospital, Sun Yet-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xueqing Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xue Qing Yu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}