NCT07738328尚未招募2 期
Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Incidence of CSA-AKI at 7 Days Post-Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Terbinafine group
Experimental
Matching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3.
干预措施: Terbinafine (Drug)
结局指标
主要结局
Incidence of CSA-AKI at 7 Days Post-Surgery
时间窗: From day of surgery through postoperative day 7
Defined according to KDIGO criteria: SCr increase ≥26.5 μmol/L within 48h, or SCr increase ≥1.5× baseline within 7d, or urine output \<0.5 mL/kg/h for ≥6h.
次要结局
- Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery(From day of surgery through postoperative day 7)
- Use of Renal Replacement Therapy Within 30 Days Post-Surgery(Within 30 days post-surgery)
- Duration of ICU stay and total hospital length of stay(Postoperative day of ICU discharge (varies, captured at the time of discharge) and postoperative day of hospital discharge (varies, captured at the time of discharge) - with data reported as cumulative days up to 30 days for ICU and up to 60 days for hos)
- Major adverse cardiovascular events within 30 days (MACE30)(Within 30 days post-surgery)
- Major adverse kidney events within 30 days (MAKE30)(Within 30 days post-surgery)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels(Pre-surgery (baseline), postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.)
- Blood cell counts, including white blood cell count (WBC), red blood cell count (RBC), and platelet count (PLT)(Postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.)
- Incidence of adverse events, including dysgeusia, rash, and gastrointestinal reactions (nausea, vomiting, diarrhea, abdominal pain, etc.)(From post-surgery to discharge (within 30-day follow-up period))
研究者
Qiquan Sun
Chief Physician, Professor
Guangdong Provincial People's Hospital
研究点 (1)
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