Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-07 @ 7:12 AM
Study NCT ID:
NCT05924269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-05
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AKI', 'timeFrame': '1-7 days', 'description': 'Development of AKI after cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'NGP', 'timeFrame': '1-7 days', 'description': 'Concentration of NGPs in Blood and Urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuronal Guidance Protein', 'Acute Kidney Injury'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective cardiac surgery followed by postoperative surveillance in the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery\n* written consent\n\nExclusion Criteria:\n\n* no written consent possible\n* Polytrauma, severe burns\n* Immunosuppression\n* Pregnancy\n* Diagnosis of Hepatitis B, Hepatitis C, and/or HIV\n* Sepsis\n* Pre-existing kidney damage'}, 'identificationModule': {'nctId': 'NCT05924269', 'acronym': 'NEUKID', 'briefTitle': 'Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)', 'orgStudyIdInfo': {'id': 'NEUKID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgery', 'description': 'Patients undergoing cardiac surgery'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andreas Körner, MD', 'role': 'CONTACT', 'email': 'andreas.koerner@med.uni-tuebingen.de', 'phone': '+497071-29 61783'}, {'name': 'Michael Koeppen, MD', 'role': 'CONTACT', 'email': 'michael.koeppen@med.uni-tuebingen.de', 'phone': '+497071-29 86935'}], 'overallOfficials': [{'name': 'Andreas Körner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic of Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}