Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-28 @ 6:20 PM
Study NCT ID:
NCT01727557
Status:
TERMINATED
Last Update Posted:
2018-03-05
First Post:
2012-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic Technique for AV Fistulae Creation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Low Accural Rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-11-15', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AV fistula success rate', 'timeFrame': 'Three months from the day of creation', 'description': 'To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.'}], 'secondaryOutcomes': [{'measure': 'Short term comfort level', 'timeFrame': 'Within three days of procedure', 'description': 'To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).'}, {'measure': 'Short term safety, number of post operative complications', 'timeFrame': 'Three days after the creation', 'description': 'b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis and AV fistula'], 'conditions': ['End Stage Renal Failure on Dialysis']}, 'descriptionModule': {'briefSummary': 'This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.', 'detailedDescription': 'The primary objectives of the study are:\n\n1. To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.\n2. To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.\n\nThe secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-70 years old\n* Able to give informed consent\n* Creation of first time AV fistula\n* Possible 3 month follow up visit\n* ASA-I-IV\n\nExclusion Criteria:\n\n* BMI ≥40\n* Repeated AV fistula creation,\n* ASA -V,\n* Allergic to local anesthetic agents,\n* Significant lung and cardiac disease,\n* Infection at the site of regional anesthesia,\n* Pre-existing peripheral nerve damage,\n* Significant bleeding disorders,'}, 'identificationModule': {'nctId': 'NCT01727557', 'briefTitle': 'Anesthetic Technique for AV Fistulae Creation', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'orgStudyIdInfo': {'id': '11-08-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthesia', 'interventionNames': ['Procedure: regional anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'regional anesthesia', 'interventionNames': ['Procedure: local anesthesia']}], 'interventions': [{'name': 'regional anesthesia', 'type': 'PROCEDURE', 'description': 'Regional anesthesia will be compared to local anesthesia', 'armGroupLabels': ['Local anesthesia']}, {'name': 'local anesthesia', 'type': 'PROCEDURE', 'description': 'Regional anesthesia will be compared to local anesthesia', 'armGroupLabels': ['regional anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Naum Shaparin', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}