Ischemic Postconditioning in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Change in cardiac index between the groups during the first postoperative day
研究概览
简要总结
Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.
详细描述
Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients > 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.
The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgery of the ascending aorta or the aortic valve
排除标准
- •Coronary artery disease requiring bypass surgery
- •Tricuspid valve surgery
- •Mitral valve surgery
- •Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
- •Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
- •Patients with autoimmune diseases
- •"Redo" operations
- •Active endocarditis (ongoing antibiotic therapy)
- •On the discretion of the operating surgeon or anaesthesiologist
结局指标
主要结局
Change in cardiac index between the groups during the first postoperative day
时间窗: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
次要结局
未报告次要终点
研究者
Mari-Liis Kaljusto
MD, PhD
Oslo University Hospital