Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-11 @ 5:41 AM
Study NCT ID:
NCT00544492
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2007-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057785', 'term': 'Catheters'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-17', 'studyFirstSubmitDate': '2007-10-15', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A. Buttonhole vs. rope ladder AV fistula cannulation, comparison of pain, anxiety, bleeding time and fistula related complications B. Rope ladder AV fistula cannulation using catheters with cylindrical vs. bevel point, comparison of pain', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arteriovenous fistula', 'dialysis access', 'pain', 'anxiety', 'fistula related complications', 'aneurysm'], 'conditions': ['Dialysis', 'Fistula']}, 'referencesModule': {'references': [{'pmid': '17170544', 'type': 'BACKGROUND', 'citation': 'Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. doi: 10.1159/000096404. Epub 2006 Dec 14.'}, {'pmid': '12234281', 'type': 'BACKGROUND', 'citation': 'Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.'}, {'pmid': '16623674', 'type': 'BACKGROUND', 'citation': 'Marticorena RM, Hunter J, Macleod S, Petershofer E, Dacouris N, Donnelly S, Goldstein MB. The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators. Hemodial Int. 2006 Apr;10(2):193-200. doi: 10.1111/j.1542-4758.2006.00094.x.'}, {'pmid': '16859201', 'type': 'BACKGROUND', 'citation': 'Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.'}, {'pmid': '7984461', 'type': 'BACKGROUND', 'citation': "Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3."}, {'pmid': '9839185', 'type': 'BACKGROUND', 'citation': 'McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. doi: 10.1016/s0020-7489(98)00039-x.'}, {'pmid': '12472802', 'type': 'BACKGROUND', 'citation': 'Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.'}, {'pmid': '9588381', 'type': 'BACKGROUND', 'citation': 'The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc. 1998 May;46(5):635-51. doi: 10.1111/j.1532-5415.1998.tb01084.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A. Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique.\n\nB. Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.\n\nThe above background information gives rise to the following investigational questions:\n\nA. Buttonhole vs rope ladder technique\n\n1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.\n2. Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.\n3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n Bleeding time is shorter when using buttonhole technique versus rope ladder technique.\n4. Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique?\n\n Hypothesis:\n\n When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.\n\n B. Rope ladder technique using catheters with cylindrical vs. bevel point\n5. Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?\n\nHypothesis:\n\nAV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.', 'detailedDescription': 'A. Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. It was described for the first time as the "contant site method" by Twardowski et al. The authors report on a patient in whom the fistula was too short to use the rope ladder technique. As an alternative, the access was cannulated at a "constant site". Later, in 1984, Krönung used the name "buttonhole puncture technique". It was used primarily in patients treated with home hemodialysis, where cannulation was performed by one single person (often by the patient himself). In order to form a perfect buttonhole it is indeed essential that the fistula is cannulated at exactly the same site and using exactly the same angle every single time. The buttonhole technique has been adopted by the recent "National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) Guidelines" for vascular access. Studies show that patient pain scores and bleeding time after dialysis are positively influenced when using this cannulation technique.\n\nB. Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.\n\nThe above background information gives rise to the following investigational questions:\n\nA. Buttonhole vs rope ladder technique\n\n1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.\n2. Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.\n3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique?\n\n Hypothesis:\n\n Bleeding time is shorter when using buttonhole technique versus rope ladder technique.\n4. Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique?\n\n Hypothesis:\n\n When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.\n\n B. Ropeladder technique using catheters with cylindrical vs. bevel point\n5. Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?\n\nHypothesis:\n\nAV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic hemodialysis\n* at least 18 years of age\n* AV fistula for vascular access\n* speaking the Dutch language\n\nExclusion Criteria:\n\n* lack of informed consent'}, 'identificationModule': {'nctId': 'NCT00544492', 'briefTitle': 'Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Study of Pain, Anxiety, Complications Related to AV Fistula Cannulation in Chronic Hemodialysis Patients. A. Buttonhole vs. Rope Ladder Technique B. Catheters With Cylindrical Point vs. Catheters With Bevel Point in Rope Ladder Technique', 'orgStudyIdInfo': {'id': 'S50619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'description': 'Buttonhole cannulation technique', 'interventionNames': ['Device: catheter for AV fistula cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2', 'description': 'Rope ladder cannulation technique', 'interventionNames': ['Device: catheter for AV fistula cannulation']}, {'type': 'EXPERIMENTAL', 'label': 'B1', 'description': 'Catheter with bevel point', 'interventionNames': ['Device: catheter for AV fistula cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B2', 'description': 'Catheter with cylindrical point', 'interventionNames': ['Device: catheter for AV fistula cannulation']}], 'interventions': [{'name': 'catheter for AV fistula cannulation', 'type': 'DEVICE', 'otherNames': ['Beldico 1425 cath', 'Beldico 1425 mf cath', 'Beldico 1425 mf cath blunt'], 'description': 'catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)', 'armGroupLabels': ['A1', 'A2', 'B1', 'B2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Bert RM Bammens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Gasthuisberg Leuven, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Bert Bammens', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}