Results of Coronary Artery Bypass Grafting in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Death
研究概览
简要总结
This study is planned to assess the effect of obesity (BMI over 30 kg / m2) on hospital outcomes of isolated coronary artery bypass grafting in patients with chronic ischemic heart disease.
详细描述
This study is planned to assess the effect of obesity (BMI over 30 kg / m2) on hospital outcomes of isolated coronary artery bypass grafting in patients with chronic ischemic heart disease.
It is planned to retrospectively enroll around 500 patients who underwent coronary artery bypass grafting for chronic ischemic heart disease at the Tomsk Research Institute of Cardiology. It is planned to develop a register of isolated coronary bypass grafting procedures, to conduct a comparative analysis of hospital results in obese patients (BMI more than 30 kg / m2) and without (BMI less than 30 kg / m2), to identify risk factors for adverse outcomes in patients of this group of patients.
Planning methods:
- Clinical status of the patient: collection of complaints, medical history, physical examination, assessment of anthropometric indicators (measurement of body weight, height, BMI), and demographic indicators before and in the control period after surgical treatment.
- General clinical examination: standard 12-lead ECG, general urine analysis, general blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and femoral arteries.
- Coronarography to assess the anatomy and condition of the coronary arteries.
- Echocardiography to assess the following parameters: mass of viable left ventricular myocardium; volumes of cardiac cavities; diameter of the mitral and tricuspid valve rings with the determination of regurgitation degree; the long axis of the ventricle; left ventricular ejection fraction; visualization of akinetic and hypokinetic myocardium; the presence of blood clots in the cavities of the heart; All surgical procedures will be performed via median sternotomy Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Intraoperative flowmetry of coronary grafts during coronary artery bypass grafting using the Medistim VeriQ System will be performed.
Postoperative data will include valuation of following indicators: mortality (hospital mortality and death from any cause); neurological injury (TIA, stroke, delirium), acute kidney injury (creatinine level prior and 1 postoperative day, urine output-up to 24-48 h, renal replacement therapy (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and troponins); inotropic support during 24-48 h (agent and dose (VIS)); length of stay (intensive care unit and total hospital days).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Clinical diagnosis of chronic ischemic heart disease
- •Indications for cardiac surgery
- •Stenosis of more than 75% of the trunk of the left coronary artery, or proximal stenosis of the anterior descending artery and/or stenosis of more than 75% of two or more coronary arteries
排除标准
- •The presence of organic heart defects of rheumatic and infectious etiology;
- •Acute myocardial infarction;
- •Less than 3 months after acute coronary or cerebrovascular events;
- •Severe pulmonary hypertension not associated with mitral regurgitation (above 75 mmHg);
- •Contraindications for operations with cardiopulmonary bypass;
- •Severe course of bronchial asthma,
- •Chronic obstructive pulmonary disease in the acute stage;
- •Refusal of the patient or relatives to participate in the study.
结局指标
主要结局
Death
时间窗: 30 days
In-hospital mortality rate (%)
次要结局
- acute kidney injury(30 days)
- Duration of mechanical ventilation(30 days)
- re-exploration(30 days)
- neurological injury(30 days)
- Duration of inotropic support(48 hours)
- postoperative transfusion(30 days)
- postoperative myocardial infarction(30 days)
- length of stay(30 days)