Protective Effect of Enhanced External Counterpulsation Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- SOFA score
研究概览
简要总结
Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Patients with Stable angina pectoris, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiogenic shock;
- •Patients chronic heart failure;
- •Patients are ready to received cardiovascular surgery during this hospital admission.
- •Patients agree to participate in the study and sign an informed consent form.
排除标准
- •Moderate to severe aortic insufficiency;
- •Dissection aneurysm;
- •Significant pulmonary hypertension; 4, A variety of bleeding diseases or bleeding tendencies, or use anticoagulants, INR>2.0; 5, active phlebitis, venous thrombosis;
- •There is an infection in the counterpulsating limb;
- •Uncontrolled hyperhypertension (>170/110mmHg);
- •Uncontrolled arrhythmias: frequent premature beats, rapid atrial fibrillation, etc.
结局指标
主要结局
SOFA score
时间窗: within the prior 7 days after cardiac surgery.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University