Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Clinical outcomes
研究概览
简要总结
The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).
This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for coronary surgery established on the basis of current published guidelines
排除标准
- •Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
- •Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
- •Left ventricle ejection fraction of 40% or less.
- •Treatment with erythropoietin (EPO) three months before the intervention
- •Hematocrit less than 35% the day prior to the procedure
- •Redo surgery
结局指标
主要结局
Clinical outcomes
时间窗: within the first 30 days (plus or minus 3 days) after surgery
Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.
次要结局
- Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.(Area Under the Concentration-Time Curve (AUC 0-48 hours))
- Biochemical outcomes(Within the first 30 days (plus or minus 3 days) after surgery)
- Operative results(Within the first 30 days (plus or minus 3 days) after surgery)