Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Myocardial injury
研究概览
简要总结
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.
详细描述
1.1 Main Objective To evaluate the protective effect of sivelestat sodium on myocardial injury after off-pump coronary artery bypass grafting (OPCABG).
Key observation indicators include: 1) Myocardial injury markers: high-sensitivity cardiac troponin T (hs-cTnT), creatine kinase isoenzyme (CK-MB), NT-proBNP; 2) Cardiac function imaging indicators: global longitudinal strain (GLS) by echocardiography, left ventricular ejection fraction (LVEF).
1.2 Secondary Objective To evaluate the protective effect of sivelestat sodium on myocardial inflammatory stress after OPCABG.
Key observation indicators include: 1) Changes in inflammatory factors (IL-6, CRP, PCT) levels; 2) Observation of clinical outcomes (mechanical ventilation time, ICU stay time, 30-day adverse events, etc.).
2.1 Research Content and Design Prospective, double-blind, randomized, placebo-controlled trial. Prospective design: Standardized data collection from patient enrollment to follow-up completion to avoid recall bias and selection bias in retrospective studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sivelestat Sodium
Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h
干预措施: Sivelestat Sodium injection 2 h after OPCABG for 72 h (Drug)
Routine therapy
Saline instead of Sivelestat
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Myocardial injury
时间窗: Day 3 after OPCABG
Sivelestat Sodium exerts a protective effect on myocardial injury after OPCABG
次要结局
- Myocardial inflammatory stress(Day 3 after OPCABG)