[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649702":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Guangdong Provincial People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Terbinafine group","EXPERIMENTAL","Matching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3.",[13],"Drug: Terbinafine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Standard of Care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Terbinafine","Terbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Qiquan Sun, Professor","CONTACT","+86 13825109488","sunqiquan@gdph.org.cn",[32],{"facility":33,"status":18,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Kidney Transplantation, Guangdong Provincial People's Hospital","Guangzhou","Guangdong","510080","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.25,23.11667,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":29,"phoneExt":18,"email":48},"Qiquan Sun","suqiquan@gdph.org.cn",{"type":50,"investigatorFullName":47,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Chief Physician, Professor","100649702","phase-2-terbinafine-for-csa-aki-prevention-100649702",false,"NCT07738328","Terbinafine for CSA-AKI Prevention","Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥18 and ≤75 years, without restriction on gender.\n* Patients with a definite clinical diagnosis scheduled for elective cardiac and macrovascular surgery with cardiopulmonary bypass (CPB) support, including but not limited to coronary artery bypass grafting (CABG), cardiac valve replacement\u002Frepair, structural heart disease surgery, aortic arch plasty, or combined procedures of the above surgeries.\n* Classified as high risk by AKI risk scoring system, with a total score ≥4 points.\n* The subject or their legal representative shall fully understand the purpose, procedures, potential risks and benefits of this study, and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Patients with severe chronic renal insufficiency (eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m² or serum creatinine \\> 300 μmol\u002FL), or those receiving any form of renal replacement therapy (e.g., hemodialysis, peritoneal dialysis).\n* Pre-existing acute kidney injury.\n* Presence of chronic or active liver diseases, including decompensated liver cirrhosis, active viral hepatitis, autoimmune liver disease, etc.; or preoperative laboratory tests showing ALT\u002FAST ≥ 2 times the upper limit of normal (ULN).\n* Severe hematological diseases (preoperative white blood cell count \\\u003C 3.0 × 10⁹\u002FL, platelet count \\\u003C 80 × 10⁹\u002FL).\n* Uncontrolled active infections, or known immunodeficiency disorders (e.g., HIV infection, status post organ transplantation).\n* History of severe hypersensitivity to terbinafine or any excipients of its formulation.\n* Pregnant or lactating women, as well as women of childbearing potential who plan to conceive during the study and refuse to use effective contraception.\n* Participation in any other clinical trial of investigational drugs or medical devices within 3 months prior to screening.\n* Patients deemed inappropriate for enrollment in this study at the investigator's clinical discretion.","ALL","18 Years","75 Years",{"count":63,"type":64},208,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Primary Objective: To evaluate the efficacy and safety of perioperative oral terbinafine in reducing the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI).Secondary Objectives:To assess the effects of terbinafine on the severity of post-cardiac surgery AKI, length of hospital stay, and 30-day major adverse kidney events (MAKE30);To evaluate its impacts on biomarkers of renal injury and inflammation.",[70,71],"Acute Kidney Injury","Cardiac Surgical Procedures",[70,73,22,74],"Cardiac Surgery-Associated Acute Kidney Injury","Randomized","NOT_YET_RECRUITING","2026-07-27",{"date":78,"type":79},"2026-07-31","ACTUAL",{"date":81,"type":64},"2026-09-01",{"date":83,"type":64},"2028-05-01",{"name":5,"class":6},1]