Sivelestat sodium treatment after off-pump coronary artery bypass grafting (OPCABG)
Official title: Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting
Run by Affiliated Hospital of Nantong University · NCT07118930 · Data updated 2026-11-12
This trial will test whether giving sivelestat sodium after off-pump coronary bypass surgery helps protect the heart and reduce inflammation in adults having OPCABG.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT07118930 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for elective off-pump coronary artery bypass grafting with at least two grafts and LVEF ≥35% who meet liver and kidney function limits and can give informed consent are ideal candidates.
✕Probably not a fit
Patients needing emergency surgery, combined valve or aortic procedures, those with significant preoperative liver/kidney dysfunction, active infection, autoimmune disease, or recent potent anti-inflammatory/immunosuppressant use are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, randomized, double-blind, placebo-controlled trial gives either sivelestat sodium or saline starting 2 hours after elective OPCABG and continuing for 72 hours. Researchers will track blood markers of myocardial injury (hs-cTnT, CK-MB, NT-proBNP), echocardiographic measures of cardiac function (GLS, LVEF), inflammatory markers (IL-6, CRP, PCT), and short-term clinical outcomes such as ventilation time, ICU stay, and 30-day adverse events. The trial enrolls adults having elective OPCABG with preserved-ish ventricular function and excludes emergency or combined major cardiac surgeries and significant preoperative liver/kidney dysfunction. All procedures and follow-up are conducted at the Affiliated Hospital of Nantong University under blinded conditions.
Why it matters
Potential benefit: If successful, sivelestat could reduce heart muscle injury and inflammation after OPCABG, potentially shortening ICU stays and improving short-term recovery.
How similar studies have gone: Sivelestat, a neutrophil elastase inhibitor, has shown anti-inflammatory benefit in some prior acute lung and ischemia–reperfusion contexts, but its use specifically after OPCABG is novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Weizhang Xiao, Dr.
- Email: xwz191201@163.com
- Phone: 8615996546951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.