Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT07091656
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-enhanced Computed Tomography and 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1463}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was the occurrence of CA-AKI defined as KDIGO (Kidney Disease Improval Global Outcomes) tage 1 or higher within seven days after contrast-enhanced CT.', 'timeFrame': 'BETWEEN 2 and 7 DAYS ATER CT -SCAN'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'contrast media', 'tomography', 'ontrast-induced nephropathy'], 'conditions': ['Contrast-associated Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': "Rationale and objectives: Since 1930 it has been accepted that intravenous injection of io-dinated contrast agent as part of contrast-enhanced computed tomography (CE-CT) imaging can induce a contrast-associated acute kidney injury (CA-AKI). For the last 10 years, studies have investigated this iatrogenia. However, those works didn't concern French population and particularly patient hospitalised after emergency department (ED) visit.\n\nThis study as-sessed the CA-AKI incidence and factor risks in patients hospitalised after a CE-CT in ED.\n\nThis was a retrospective cohort observational study in the ED of the Beaujon University Hospital between October 31st 2019 to January 24th 2022.\n\nPatients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible. To be included, patients were required to have at least two creatinine measurements: one taken within 24 hours before CT and a second measurement taken between 48 hours to the seventh day following the initial test. The CT examination had to be performed at Beaujon Hospital with the injection of iodinated contrast agents such as IOMERON® (iomeprol) or XENETIX® (iobitridol)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible. To be included, patients were required to have at least two creatinine measurements: one taken within 24 hours before CT and a sec-ond measurement taken between 48 hours to the seventh day following the initial test. The CT examination had to be performed at Beaujon Hospital with the injection of iodinated contrast agents such as IOMERON® (iomeprol) or XENETIX® (iobitridol).\n\nExclusion Criteria:\n\n* Patients were excluded from the study if they did not have two creatinine measurements meeting the specified criteria. If multiple contrast-enhanced CT examinations were per-formed within a seven-day period for the same patient, only the first examination was in-cluded in the study, while subsequent scans were excluded.'}, 'identificationModule': {'nctId': 'NCT07091656', 'briefTitle': 'Contrast-enhanced Computed Tomography and Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Beaujon Hospital'}, 'officialTitle': 'Incidence and Risk Factors of Contrast-associated Acute Kidney Injury in Patients Hospitalised After Contrast-enhanced Computed Tomography in the Emergency Department', 'orgStudyIdInfo': {'id': 'urgBjNPC-AKI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'there is no intervention', 'type': 'OTHER', 'description': 'NO INTERVENTION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'state': 'Île-de-France (Paris)', 'country': 'France', 'facility': 'Hopital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaujon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Prabakar VAITTINADA AYAR', 'investigatorAffiliation': 'Beaujon Hospital'}}}}