Study of Sivelestat Sodium in OPCABG
Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting
Affiliated Hospital of Nantong University
62 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if drug Sivelestat Sodium works to improve the prognosis of off-pump coronary artery bypass grafting (OPCABG) in adults. It will also learn about the safety of drug Sivelestat Sodium. The main questions it aims to answer are: * Does drug Sivelestat Sodium have a protective effect on myocardial injury after OPCABG? * Does Sivelestat Sodium exert a protective effect on myocardial inflammatory stress after OPCABG? Researchers will compare drug Sivelestat Sodium to a placebo (a look-alike substance that contains no drug) to see if drug Sivelestat Sodium works to protect myocardium following OPCABG. Participants will: * Accept drug Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h. * Undergo a series of blood tests and echocardiography examinations after the OPCABG.
Eligibility
Inclusion Criteria1
- Undergoing elective OPCABG (≥2 bridged vessels). LVEF≥35%, no severe liver or kidney function abnormalities (ALT/AST≤3 times the upper limit, eGFR≥60 mL/min). Sign the informed consent form.
Exclusion Criteria4
- Emergency operation, combined valve surgery or aortic surgery. Usage of immunosuppressants or potent anti-inflammatory drugs within 30 days before the operation.
- Active infections, autoimmune diseases, and allergy history.
- Preoperative liver and kidney dysfunction
- Severe cardiopulmonary insufficiency before the operation.
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Interventions
Sivelestat Sodium injection 2 h after OPCABG for 72 h
Saline (0.9% NaCl) instead of Sivelestat
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07118930