Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 10:35 AM
Study NCT ID:
NCT04270292
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy
Sponsor:
Organization:
Raw JSON
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There is two options about fistula direction as antegrade or retrograde.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Cannulation Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arteriovenous Fistula Cannulation Group', 'description': "The cannulation practices' of patients was asked to the nurses and patients."}], 'classes': [{'title': 'Area puncture', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Rope ladder', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Buttunhole', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': "The hemodialysis nurse who cannulate the patient's fistula fill the data form. There is three options about cannulation method as puncture, buttonhole, and rope ladder methods.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Fistula Needle Rotated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arteriovenous Fistula Cannulation Group', 'description': "The cannulation practices' of patients was asked to the nurses and patients."}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'The researchers look to the fistula needle while it inserts to the fistula. There is two options as needle rotation is yes or no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Arterial and Venous Needle Been on the Same Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arteriovenous Fistula Cannulation Group', 'description': "The cannulation practices' of patients was asked to the nurses and patients."}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks', 'description': 'The researchers look to the arterial and venous line whether they are the same venous line.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arteriovenous Fistula Cannulation Group', 'description': "The cannulation practices' of patients was asked to the nurses and patients."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arteriovenous Fistula Cannulation Group', 'description': "The cannulation practices' of patients was asked to the nurses and patients."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-20', 'size': 382526, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-30T11:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-02-12', 'resultsFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-12', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Fistula Needle Direction', 'timeFrame': 'up to 12 weeks', 'description': "The hemodialysis nurse who cannulate the patient's fistula fill the data form. There is two options about fistula direction as antegrade or retrograde."}, {'measure': 'Number of Cannulation Method', 'timeFrame': 'up to 12 weeks', 'description': "The hemodialysis nurse who cannulate the patient's fistula fill the data form. There is three options about cannulation method as puncture, buttonhole, and rope ladder methods."}, {'measure': 'Number of Fistula Needle Rotated', 'timeFrame': 'up to 12 weeks', 'description': 'The researchers look to the fistula needle while it inserts to the fistula. There is two options as needle rotation is yes or no.'}, {'measure': 'Number of Arterial and Venous Needle Been on the Same Line', 'timeFrame': 'up to 12 weeks', 'description': 'The researchers look to the arterial and venous line whether they are the same venous line.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arteriovenous fistula', 'Antegrade direction', 'Dialysis adequacy', 'Nursing care', 'Cannulation practices'], 'conditions': ['Arteriovenous Fistula', 'Hemodialysis', 'Dialysis Adequacy']}, 'referencesModule': {'references': [{'pmid': '31151432', 'type': 'BACKGROUND', 'citation': 'Coventry LL, Hosking JM, Chan DT, Coral E, Lim WH, Towell-Barnard A, Twigg DE, Rickard CM. Variables associated with successful vascular access cannulation in hemodialysis patients: a prospective cohort study. BMC Nephrol. 2019 May 31;20(1):197. doi: 10.1186/s12882-019-1373-3.'}, {'pmid': '28263032', 'type': 'BACKGROUND', 'citation': 'Elias M, Nnang-Obada E, Charpentier B, Durrbach A, Beaudreuil S. Impact of arteriovenous fistula cannulation on the quality of dialysis. Hemodial Int. 2018 Jan;22(1):45-49. doi: 10.1111/hdi.12539. Epub 2017 Mar 6.'}, {'pmid': '21688239', 'type': 'BACKGROUND', 'citation': 'Gauly A, Parisotto MT, Skinder A, Schoder V, Furlan A, Schuh E, Marcelli D. Vascular access cannulation in hemodialysis patients - a survey of current practice and its relation to dialysis dose. J Vasc Access. 2011 Oct-Dec;12(4):358-64. doi: 10.5301/JVA.2011.8413.'}, {'pmid': '33492745', 'type': 'DERIVED', 'citation': 'Ozen N, Aydin Sayilan A, Sayilan S, Mut D, Akin EB, Ecder ST. Relationship between arteriovenous fistula cannulation practices and dialysis adequacy: A prospective, multicenter study. J Ren Care. 2022 Mar;48(1):41-48. doi: 10.1111/jorc.12365. Epub 2021 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Arteriovenous fistulae are preferred among methods of providing blood access for hemodialysis. For each hemodialysis treatment, the fistula is cannulated usually with two needles. One, the arterial needle, allows the blood to be withdrawn from the patient into the dialysis circuit and then it is returned by the second or venous needle. The success of arteriovenous fistula cannulation is dependent on many variables and these are affect the dialysis adequacy.', 'detailedDescription': "As hemodialysis prescriptions are usually three times weekly (4 to 8 h), a fistula or graft for hemodialysis will be punctured twice each dialysis treatment or at least 312 times per year. To allow healing of the tissues damaged during each cannulation, optimal cannulation practice is required by rotation of the needle insertion sites each dialysis treatment. Vascular access (VA) has been justly described as both the lifeline and the Achilles' heel of hemodialysis therapy, making blood purification itself possible while simultaneously often constituting a limiting factor in treatment adequacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Being on hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months and 18 and older years of age who has arteriovenous fistula', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and older years of age\n* Have arteriovenous fistula\n* Being on hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months\n* Volunteering to participate in the study\n* Have not communication problem\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Not volunteering to participate in the study\n* Have communication problem\n* Being on shorter hemodialysis therapy for 4 hours a day on 3 days per week for at least 6 months'}, 'identificationModule': {'nctId': 'NCT04270292', 'briefTitle': 'Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Demiroglu Bilim University'}, 'officialTitle': 'Arteriovenous Fistula Cannulation Methods and Dialysis Adequacy: A Cross-sectional Study From Turkey', 'orgStudyIdInfo': {'id': 'P0139R00'}}, 'contactsLocationsModule': {'locations': [{'zip': '34360', 'city': 'Istanbul', 'state': 'Sisli', 'country': 'Turkey (Türkiye)', 'facility': 'Demiroglu Bilim University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nurten Ozen, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Demiroglu Bilim University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Demiroglu Bilim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nurten Ozen', 'investigatorAffiliation': 'Istanbul Demiroglu Bilim University'}}}}