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Not yet recruiting NCT07738328

Terbinafine for CSA-AKI Prevention

Phase II Interventional Acute Kidney Injury Cardiac Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Terbinafine.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Cardiac Surgical Procedures. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Incidence of CSA-AKI at 7 Days Post-Surgery [Time frame: From day of surgery through postoperative day 7]
Secondary outcome measures (8)
  • Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery [Time frame: From day of surgery through postoperative day 7]
  • Use of Renal Replacement Therapy Within 30 Days Post-Surgery [Time frame: Within 30 days post-surgery]
  • Duration of ICU stay and total hospital length of stay [Time frame: 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) [Time frame: Within 30 days post-surgery]
  • Major adverse kidney events within 30 days (MAKE30) [Time frame: Within 30 days post-surgery]
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels [Time frame: 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) [Time frame: 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.) [Time frame: From post-surgery to discharge (within 30-day follow-up period)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Department of Kidney Transplantation, Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07738328 · KY2026-378-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗