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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
208
Terbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery
Department of Kidney Transplantation, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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 7
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 7
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-surgery
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 hos
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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-surgery
Major adverse kidney events within 30 days (MAKE30)
Data obtained from electronic medical records. MAKE30 is defined as all-cause death, new RRT (any modality), or ≥25% decline in eGFR from baseline within 30 days post-surgery. eGFR is calculated using the CKD-EPI formula; baseline is defined as the most recent pre-operative value.
Time frame: Within 30 days post-surgery
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels
Peripheral venous blood samples are collected and sent to the central laboratory for serum ALT and AST measurement using an automated biochemical analyzer. Normal reference ranges and assay methods follow each center's standard operating procedures.
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)
Peripheral venous blood samples are collected and measured using an automated hematology analyzer
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.)
Adverse events are recorded based on investigator inquiry and subject self-report, including event name, onset time, severity, duration, outcome, and causality with the study drug. Severity is graded according to CTCAE 5.0 criteria (Grade 1-5), and causality with the study drug is determined by the investigator
Time frame: From post-surgery to discharge (within 30-day follow-up period)