Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia and Continuous Controlled Warm Shot Through Vein Grafts During Proximal Ends Anastomosis in Conventional CABG
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 主要终点
- Post-op CK-MB Levels
研究概览
简要总结
In spite improvements in methods of myocardial protection, peri-operative myocardial damage is still the commonest cause of early morbidity and mortality after technically successful CABG Surgery. What is the optimum method of myocardial protection is still debatable.
The investigators conducted this study to see effects of multiport antegrade cold blood cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion through veins graft during proximal ends anastomosis in conventional CABG surgery in patients having multi-vessel disease.
详细描述
A prospective randomized controlled study was conducted between April-2013 and June-2014, in the Department of Cardiac Surgery, Chaudary Pervaiz Elahi Institute of cardiology (CPEIC) Multan, Pakistan. The CPEIC is a tertiary cardiac care center and is presently performing over 600 coronary artery bypass surgery annually. The study was conducted in strict compliance of the rules established by the revised Helsinki convention and had approval from the ethical committee of the institute.
Patients undergoing isolated conventional CABG were included in the study except; The redo CABG, those who required 2 or less than 2 grafts, patients who had major postoperative neurological complications like stroke, 2nd arterial graft along with LIMA, patients who need CABG within a week of STEMI or NSTEMI and Patients with calcified or diseased aorta in which single cross clamp technique was used for proximal aorto-coronary anastomosis.
The patients were randomized into two groups by using draw randomization technique. The investigators made 112 sets, each set containing four patients. The staff nurse on duty was requested to pick up the two folded papers from four containing hidden identity of the patients. The patients chosen by draw were included in the study group, others in the control group.
Group I: Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts (Study Group) and Group II: Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion (Control Group).
All operations were carried out by two consultant surgeons at the investigators institution, who are certified cardiac surgeons with sufficient experience. Patients were premedicated with oral dose of 3mg bromazepam the night before surgery. Anaesthesia was induced with intra-venous morphine (0.1mg/kg), midazolam (0.05-0.1 mg /kg), and propofol (1.0-2.5 mg/kg titrated according to the response. They were given atracuronium (1mg/kg) before endotracheal intubation. The anaesthesia was maintained with sevoflorane/isoflurane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing isolated conventional CABG were included in the study
排除标准
- •The redo CABG surgery. Those who required 2 or less than 2 grafts. Patients who had major postoperative neurological complications like stroke. 2nd arterial graft along with LIMA. Patients who need CABG within a week of STEMI or NSTEMI. Patients with calcified or diseased aorta in which single cross clamp technique was used for proximal aorto-coronary anastomosis
结局指标
主要结局
Post-op CK-MB Levels
时间窗: 36 hours after surgery.
CK-MB is a marker of Myocardial Damage.
次要结局
- Pharmacologic Inotropic Support (Adrenaline)(Upto 1 week after sugery)
- Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support(24 hours before surgery and upto 1 week of surgical procedure.)
- Operative Mortality(Within 30 days after surgical Procedure)
- Pharmacological Inotropic Support (Nor-adrenaline)(Upto 1 week after sugery)
- Pharamacological Inotropic Support (Dobutamine)(Upto 1 week after sugery)
研究者
Muhammad Sher-i-Murtaza
senior registrar cardiac surgery, Multan institute of cardiology, multan, pakistan.
Chaudhry Pervaiz Elahi Institute of Cardiology
