RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s, and allergy history. - Preoperative liver and kidney dysfunction - Severe cardiopulmonary insufficiency before the operation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Sivelestat Sodium injection 2 h after OPCABG for 72 h

DRUG

Saline (0.9% NaCl)

Saline (0.9% NaCl) instead of Sivelestat

Locations (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China