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临床试验/NCT02303704
NCT02303704已完成2 期

Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia and Continuous Controlled Warm Shot Through Vein Grafts During Proximal Ends Anastomosis in Conventional CABG

Chaudhry Pervaiz Elahi Institute of Cardiology0 个研究点目标入组 448 人开始时间: 2013年4月1日最近更新:
适应症

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

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

发起方
Chaudhry Pervaiz Elahi Institute of Cardiology
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Sher-i-Murtaza

senior registrar cardiac surgery, Multan institute of cardiology, multan, pakistan.

Chaudhry Pervaiz Elahi Institute of Cardiology

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