Terbinafine for CSA-AKI Prevention

Официальное название

Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Incidence of CSA-AKI at 7 Days Post-Surgery [Срок оценки: From day of surgery through postoperative day 7]

Вторичные конечные точки (8)

• Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery [Срок оценки: From day of surgery through postoperative day 7]
• Use of Renal Replacement Therapy Within 30 Days Post-Surgery [Срок оценки: Within 30 days post-surgery]
• Duration of ICU stay and total hospital length of stay [Срок оценки: 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) [Срок оценки: Within 30 days post-surgery]
• Major adverse kidney events within 30 days (MAKE30) [Срок оценки: Within 30 days post-surgery]
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels [Срок оценки: 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) [Срок оценки: 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.) [Срок оценки: From post-surgery to discharge (within 30-day follow-up period)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Department of Kidney Transplantation, Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07738328 · KY2026-378-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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