Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 12:13 PM
Study NCT ID:
NCT04470661
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-care Ultrasound for Acute Kidney Injury
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic accuracy of POCUS in the patients with AKI', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute kidney injury diagnosed in the ED.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• AKI diagnosis according to KDIGO criteria\n\nExclusion Criteria:\n\n* Patients with end stage renal failure,\n* Failure to perform POCUS in the first two hours of presentation of patient,\n* Those with renal malignancy,\n* Pregnant women,\n* Renal transplantation patients,\n* Patients with a single kidney,\n* Those with polycystic kidney disease,\n* Patients with nephrostomy,\n* Patients who are referred from another center,\n* Unable to perform adequate imaging,\n* Patients who do not give consent for the study will be excluded.'}, 'identificationModule': {'nctId': 'NCT04470661', 'briefTitle': 'Point-of-care Ultrasound for Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Diagnostic Accuracy of Point-of-Care Ultrasound in the Etiology of Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'GaziU-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care ultrasound:\n\n1. Kidney length and echogenity,\n2. Bladder scanning\n3. VCI measures\n4. Lung B lines and effusion\n5. Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Facaulty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehmet Aslaner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mehmet Ali Aslaner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Mehmet Ali Aslaner', 'investigatorAffiliation': 'Gazi University'}}}}