[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07197957":3,"trial-entities:NCT07197957":117,"trial-summary:NCT07197957":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":32,"sex":35,"minimum_age":36,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":37,"std_ages":54,"locations":57,"central_contacts":109,"overall_officials":114,"references":115,"see_also_links":116},"NCT07197957","Cystatin & Early AKI Detection","Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury","Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury","RECRUITING","2027-02-28","2025-09","2025-09-30","2025-03-11","BayCare Health System","OTHER",false,"To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).","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.",[19],"Acute Kidney Injury",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},100,"ESTIMATED",[],[29],{"measure":30,"timeFrame":31},"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","10 days",[33],{"measure":34,"timeFrame":31},"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","ALL","18 Years",{"inclusion":38,"exclusion":44,"raw_text":53},[39,40,41,42,43],"Subjects ages 18 years and above","Inpatients with CKD (Figure 1)","Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.","Pre and post contrast available","All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.",[45,46,47,48,49,50,51,52],"Preexisting dialysis","Patients under the age of 18 years","Pregnancy","Incarcerated individuals","Patients with impaired cognition and unable to follow consent procedures","Recent exposure to CM (within 2 days before\u002Fafter procedure)","Cardiac shock","Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim","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\u002Fafter procedure)\n* Cardiac shock\n* Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim",[55,56],"ADULT","OLDER_ADULT",[58,73,85,97],{"facility":59,"status":8,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":70},"Morton Plant Hospital","Clearwater","Florida","33756","United States",[65],{"name":66,"role":67,"phone":68,"email":69},"Andrea Daigneault, RN","CONTACT","727-754-9028","andrea.daigneault@baycare.org",{"lat":71,"lon":72},27.96585,-82.8001,{"facility":74,"status":8,"city":75,"state":61,"zip":76,"country":63,"contacts":77,"geoPoint":82},"Morton Plant North Bay Hospital","New Port Richey","34652",[78],{"name":79,"role":67,"phone":80,"email":81},"Enrique Rincon, MD","727-375-7929","enrique.rincon@baycare.org",{"lat":83,"lon":84},28.24418,-82.71927,{"facility":86,"status":8,"city":87,"state":61,"zip":88,"country":63,"contacts":89,"geoPoint":94},"Mease Countryside Hospital","Safety Harbor","34695",[90],{"name":91,"role":67,"phone":92,"email":93},"Jonathan Frunzi, MD","(727) 725-6111","johnathan.frunzi@baycare.org",{"lat":95,"lon":96},27.99085,-82.69316,{"facility":98,"status":8,"city":99,"state":61,"zip":100,"country":63,"contacts":101,"geoPoint":106},"St. Anthony's Hospital","St. Petersburg","33705",[102],{"name":103,"role":67,"phone":104,"email":105},"Sarah Al-Obaydi, MD","727-825-1236","sarah.alobaydi@baycare.org",{"lat":107,"lon":108},27.77086,-82.67927,[110],{"name":111,"role":67,"phone":112,"email":113},"Tracy Johns, PharmD","727-519-1310","tracy.johns@baycare.org",[],[],[],{"nct_id":4,"conditions":118,"biomarkers":121},[119,120],"Acute Renal Failure","Chronic Kidney Disease",[],{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an observational study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.","completed","Observational Study on Cystatin C for Early Detection of Acute Kidney Injury","This observational study aims to understand if a blood test for cystatin C (sCyC) can detect acute kidney injury (AKI) earlier than the standard blood test for creatinine (sCr). Researchers are looking at how often AKI occurs when using sCr compared to sCyC, 24-48 hours after receiving contrast media (like isohexol Omnipaque) for a CT scan or coronary angiography, and again 7-10 days later. You may be able to join if you are 18 years or older, are an inpatient with chronic kidney disease (CKD), and are scheduled for a CT scan or coronary angiography involving contrast media. The study is looking to enroll 100 participants. The current recruitment status is unclear.","Participants will be followed up 24-48 hours after contrast media and again at 7-10 days.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]