Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
Weizhang Xiao, Dr.
xwz191201@163.com
8615996546951
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 62
Treatments
Experimental: Sivelestat Sodium
Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h
Placebo_comparator: Routine therapy
Saline instead of Sivelestat
Sponsors
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov