Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 7:07 PM
Study NCT ID:
NCT04087161
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury after open TAAA repair', 'timeFrame': '90 days after surgery', 'description': 'Acute kidney injury defined according to the KDIGO classification and its association with the Nephrocheck assessment results'}], 'secondaryOutcomes': [{'measure': 'Mortality, major adverse events such as any complication', 'timeFrame': '90 days after surgery', 'description': 'Any severe adverse Outcome after open TAAA repair and its association with the Nephrocheck assessment results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Early Assessment of AKI After TAAA Repair']}, 'referencesModule': {'references': [{'pmid': '37423933', 'type': 'DERIVED', 'citation': 'Doukas P, Frese JP, Eierhoff T, Hellfritsch G, Raude B, Jacobs MJ, Greiner A, Oberhuber A, Gombert A. The NephroCheck bedside system for detecting stage 3 acute kidney injury after open thoracoabdominal aortic repair. Sci Rep. 2023 Jul 9;13(1):11096. doi: 10.1038/s41598-023-38242-2.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.\n\nMulticentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective, open TAAA repair', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nelective open TAAA repai\n\n18-80 years\n\nno pregnancy\n\nExclusion Criteria:\n\nemergency treatment participation in another Trial renal replacement therapy'}, 'identificationModule': {'nctId': 'NCT04087161', 'briefTitle': 'Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery', 'orgStudyIdInfo': {'id': '29012015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nephrocheck bed side testing of AKI', 'type': 'OTHER', 'description': 'Usage of Nephrocheck system to assess AKI after open TAAA repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Münster, University Hospital, Department of Vascular Surgery', 'class': 'UNKNOWN'}, {'name': 'Berlin, University medicine Charité, Department of Vascular Surgery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Alexander Gombert', 'investigatorAffiliation': 'RWTH Aachen University'}}}}