Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT07197957
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cystatin and Early AKI Detection Contrast Induced 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in eGFRcr compared to change from baseline in eGFRcys 24-48 hours after contrast media and at 7 to 10 days follow-up', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).', 'detailedDescription': 'The primary objective of this study is to evaluate the clinical utility of Cystatin C in early detection of contrast-induced AKI.\n\nTo evaluate the effect of patient characteristics in the Cystatin C based GFR estimation in comparison to Cr based estimation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Study participants will be a cohort of inpatients with CKD. Eligible study participants, as defined by the inclusion criteria, will be consented at Morton Plant North Bay Hospital, Mease Countryside Hospital, and Morton Plant Hospital and St. Anthony's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects ages 18 years and above\n* Inpatients with CKD (Figure 1)\n* Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.\n* Pre and post contrast available\n* All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.\n\nExclusion Criteria:\n\n* Preexisting dialysis\n* Patients under the age of 18 years\n* Pregnancy\n* Incarcerated individuals\n* Patients with impaired cognition and unable to follow consent procedures\n* Recent exposure to CM (within 2 days before/after procedure)\n* Cardiac shock\n* Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim'}, 'identificationModule': {'nctId': 'NCT07197957', 'briefTitle': 'Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'BayCare Health System'}, 'officialTitle': 'Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'Cystatin & Early AKI Detection'}}, 'contactsLocationsModule': {'locations': [{'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Daigneault, RN', 'role': 'CONTACT', 'email': 'andrea.daigneault@baycare.org', 'phone': '727-754-9028'}], 'facility': 'Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Enrique Rincon, MD', 'role': 'CONTACT', 'email': 'enrique.rincon@baycare.org', 'phone': '727-375-7929'}], 'facility': 'Morton Plant North Bay Hospital', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34695', 'city': 'Safety Harbor', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Frunzi, MD', 'role': 'CONTACT', 'email': 'johnathan.frunzi@baycare.org', 'phone': '(727) 725-6111'}], 'facility': 'Mease Countryside Hospital', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Al-Obaydi, MD', 'role': 'CONTACT', 'email': 'sarah.alobaydi@baycare.org', 'phone': '727-825-1236'}], 'facility': "St. Anthony's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'centralContacts': [{'name': 'Tracy Johns, PharmD', 'role': 'CONTACT', 'email': 'tracy.johns@baycare.org', 'phone': '727-519-1310'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BayCare Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}