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NCT07738328
Terbinafine for CSA-AKI Prevention
Conditions: Acute Kidney Injury, Cardiac Surgical Procedures
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 208
Sponsor: Guangdong Provincial People's Hospital
Location: Department of Kidney Transplantation, Guangdong Provincial People's Hospital Guangzhou Guangdong
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Aged ≥18 and ≤75 years, without restriction on gender.
* 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/repair, structural heart disease surgery, aortic arch plasty, or combined procedures of the above surgeries.
* Classified as high risk by AKI risk scoring system, with a total score ≥4 points.
* 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.
Exclusion Criteria:
* Patients with severe chronic renal insufficiency (eGFR \< 50 mL/min/1.73 m² or serum creatinine \> 300 μmol/L), or those receiving any form of renal replacement therapy (e.g., hemodialysis, peritoneal dialysis).
* Pre-existing acute kidney injury.
* Presence of chronic or active liver diseases, including decompensated liver cirrhosis, active viral hepatitis, autoimmune liver disease, etc.; or preoperative laboratory tests showing ALT/AST ≥ 2 times the upper limit of normal (ULN).
* Severe hematological diseases (preoperative white blood cell count \< 3.0 × 10⁹/L, platelet count \< 80 × 10⁹/L).
* Uncontrolled active infections, or known immunodeficiency disorders (e.g., HIV infection, status post organ transplantation).
* History of severe hypersensitivity to terbinafine or any excipients of its formulation.
* Pregnant or lactating women, as well as women of childbearing potential who plan to conceive during the study and refuse to use effective contraception.
* Participation in any other clinical trial of investigational drugs or medical devices within 3 months prior to screening.
* Patients deemed inappropriate for enrollment in this study at the investigator's clinical discretion.
Source: ClinicalTrials.gov (NCT07738328). StuddyBuddy aggregates publicly available trial information.