Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-25 @ 2:39 AM
Study NCT ID:
NCT02580292
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2015-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-09', 'studyFirstSubmitDate': '2015-10-17', 'studyFirstSubmitQcDate': '2015-10-17', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury - Lassnigg grade-minimal', 'timeFrame': '2nd postoperative day', 'description': 'Based on change in creatinine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.', 'detailedDescription': 'To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>= 18 years\n* undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement\n\nExclusion Criteria:\n\n* chronic kidney diseases (estimated GFR \\< 60 ml/min/1.73m2)\n* prior carotid endarterectomy\n* known carotid artery stenosis of 50% or greater\n* dissection or aneurysm involving renal or carotid arteries\n* scheduled aortic or aortic valve surgery\n* heart transplant\n* intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.'}, 'identificationModule': {'nctId': 'NCT02580292', 'briefTitle': 'Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.', 'orgStudyIdInfo': {'id': '1'}}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cardiovascular Center - University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Milo Engoren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Milo Engoren', 'investigatorAffiliation': 'University of Michigan'}}}}