Terbinafine for CSA-AKI Prevention
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Terbinafine
DrugTerbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Terbinafine groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of CSA-AKI at 7 Days Post-Surgery
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.
Time frame
From day of surgery through postoperative day 7Secondary outcomes
1
Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery
AKI severity is assessed by the maximum KDIGO stage within 7 days post-surgery, based on serum creatinine and urine output criteria. Stage 1: SCr increase ≥26.5 μmol/L within 48h, or increase to 1.5-1.9× baseline within 7d, or urine output \<0.5 mL/kg/h for 6-12h; Stage 2: SCr increase to 2.0-2.9× baseline, or urine output \<0.5 mL/kg/h for ≥12h; Stage 3: SCr increase to ≥3.0× baseline, or SCr ≥353.6 μmol/L, or initiation of RRT, or urine output \<0.3 mL/kg/h for ≥24h, or anuria for ≥12h. The highest stage reached within the 7-day period is recorded.
Time frame
From day of surgery through postoperative day 72
Use of Renal Replacement Therapy Within 30 Days Post-Surgery
Documentation of whether the subject received any form of renal replacement therapy (including continuous renal replacement therapy, intermittent hemodialysis, peritoneal dialysis, etc.) within 30 days after surgery, based on clinical orders and treatment records. Binary outcome: yes/no.
Time frame
Within 30 days post-surgery3
Duration of ICU stay and total hospital length of stay
Data obtained from the hospital electronic medical record system or inpatient records. ICU stay is defined as the total number of days the subject spent in the ICU post-surgery (from ICU admission after surgery to ICU discharge). Total hospital length of stay is defined as the total number of days of hospitalization post-surgery (from the day of surgery to hospital discharge).
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 hos4
Major adverse cardiovascular events within 30 days (MACE30)
Data obtained from electronic medical records. MACE30 is defined as all-cause death, nonfatal myocardial infarction, or nonfatal stroke within 30 days post-surgery
Time frame
Within 30 days post-surgeryOther outcomes
1
Cardiac troponin T (cTnT), creatine kinase-MB (CK-MB), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
Peripheral venous blood samples are collected; cTnT and NT-proBNP are measured by electrochemiluminescence immunoassay, and CK-MB by immunoinhibition assay
Time frame
Pre-surgery (baseline), 24 hours post-surgery, 48 hours post-surgery, and 72 hours post-surgery2
Serum concentrations of IL-6, CRP, Cystatin C, MDA, TXB₂, and HSP70
Time frame
At baseline (immediately before surgery), at 6 hours after the end of surgery, and at 24 hours after the end of surgery3
Urinary concentrations of NGAL and KIM-1 (renal tubular injury biomarkers)
Time frame
Baseline (prior to surgery), 6 hours after surgery, 24 hours after surgery, and 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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