Terbinafine for CSA-AKI Prevention

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT07738328
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Cardiac Surgical Procedures

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Terbinafine — DRUG
    Terbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Apr 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Terbinafine group
    Matching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3.
  • No Intervention: Control group
    Standard of Care

Primary Outcome Measure

Incidence of CSA-AKI at 7 Days Post-Surgery [ Time Frame: From day of surgery through postoperative day 7 ]

Central Contacts

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