Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT01897857
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018616', 'term': 'Ultrasonography, Doppler, Duplex'}], 'ancestors': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the compensatory changes in ulnar artery blood flow after radial artery cannulation', 'timeFrame': 'Change from Baseline in ulnar artery blood before anesthesia, before cannulation, 5 min after cannultion, 20 min after removal of the arterial catheter, 24 hous after cannulation', 'description': 'to evaluate the compensatory changes in ulnar artery blood flow after radial artery cannulation using duplex Doppler ultrasonography at each time point'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus(DM)', 'radial artery cannulation', 'artery blood flow', 'complication', 'End stage renal disease undergoing kidney transplantation'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. The radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. Atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. Especially in patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and perhaps calcification. In a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with DM. In our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing elective kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 20yrs undergoing kidney transplantation\n* ASA physical status ≥ 3\n* patients with DM (DM group), patients without DM (nonDM group)\n\nExclusion Criteria:\n\n* coagulopathy\n* inflammation or infection at the puncture site for cannulation\n* a positive result on the modified Allen's test\n* the cannulation failed twice\n* Acute renal allograft rejection"}, 'identificationModule': {'nctId': 'NCT01897857', 'briefTitle': 'Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DM kidney transplantation', 'description': 'patient with DM undergoing undergoing kidney transplantation', 'interventionNames': ['Device: duplex Doppler ultrasonography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'without DM undergoing kidney transplantation', 'description': 'patient without DM undergoing undergoing kidney transplantation', 'interventionNames': ['Device: duplex Doppler ultrasonography']}], 'interventions': [{'name': 'duplex Doppler ultrasonography', 'type': 'DEVICE', 'armGroupLabels': ['DM kidney transplantation', 'without DM undergoing kidney transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}