Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-10 @ 2:34 AM
Study NCT ID:
NCT04144894
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2019-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Biosonographic Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic factor of Shear Wave Elastography', 'timeFrame': 'From the time of Informed Consent being given to 96 hours after consent being given', 'description': "Shear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '33201924', 'type': 'DERIVED', 'citation': 'Zaky A, Beck AW, Bae S, Sturdivant A, Liwo A, Zdenek N, McAnally N, Ahmad S, Meers B, Robbin M, Pittet JF, Tolwani A, Berkowitz D. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study. PLoS One. 2020 Nov 17;15(11):e0241782. doi: 10.1371/journal.pone.0241782. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of diabetes or hypertension\n* Estimated Glomerular Filtration Rate \\> 60 ml/min/m\\^2\n* Structurally normal kidney on renal ultrasound\n* BMI \\< 27 kg/m\\^2\n\nExclusion Criteria:\n\n* Prisoners directly admitted from a correctional facility\n* Children \\< 19 years or under 50 kg body weight if age is unknown\n* Patients with end stage renal disease or preexisting glomerular filtration rate less than or equal to 30 mL/min/1.73 m\\^2 or need for dialysis\n* Patients with end stage heart disease on the cardiac transplant list\n* Patients undergoing procedures without vascular surgery\n* All transplant patients\n* Patients on ventricular assist devices\n* Patients undergoing emergency procedures\n* Patients with body mass index \\> 27kg/m\\^2\n* Any condition that would impede visualization of the kidneys by ultrasound'}, 'identificationModule': {'nctId': 'NCT04144894', 'briefTitle': 'The Biosonographic Index', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.', 'orgStudyIdInfo': {'id': 'IRB-300003010'}, 'secondaryIdInfos': [{'id': 'UAB', 'type': 'OTHER', 'domain': 'Anesthesiology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Controls', 'interventionNames': ['Diagnostic Test: Shear Wave Elastography']}, {'type': 'OTHER', 'label': 'Vascular Surgery Subjects', 'interventionNames': ['Diagnostic Test: Shear Wave Elastography']}], 'interventions': [{'name': 'Shear Wave Elastography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Advanced ultrasound technique', 'armGroupLabels': ['Healthy Controls', 'Vascular Surgery Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Sturdivant, MPH', 'role': 'CONTACT', 'email': 'Adamsturdivant@uabmc.edu', 'phone': '205-934-4042'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Adam B Sturdivant, MPH', 'role': 'CONTACT', 'email': 'Adamsturdivant@uabmc.edu', 'phone': '205-934-4042'}, {'name': 'Ayesha Bryant, MD, MSPH', 'role': 'CONTACT', 'email': 'Asbryant@uabmc.edu', 'phone': '205-996-7383'}], 'overallOfficials': [{'name': 'Ahmed Zaky, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Zaky', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}