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Study of Sivelestat Sodium in OPCABG

RecruitingPhase 2Ages 18 Years - 75 YearsAllAffiliated Hospital of Nantong University
NCT07118930 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Sivelestat Sodium injection 2 h after OPCABG for 72 h
  • Saline (0.9% NaCl)
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Where

1 site
Affiliated Hospital of Nantong University
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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