Perioperative Administration of Erythromycin and Brain Protection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- biochemical markers of brain ischemia and intraoperative cerebral oxymetry data
研究概览
简要总结
Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery.
The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery.
详细描述
First Version: Study Protocol Authors: Thomaidou E., Vretzakis G., Argiriadou E., Stamatiou G., et al.
Perioperative administration of erythromycin and brain protection
Study Setting: On-pump, planned cardiac surgery. Randomized, double blinded clinical trial of two parallel groups. Group A: control group. Group B: erythromycin group (dose 25mg/kg intravenously).
Purpose:
Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients < 80 years old scheduled for elective cardiac surgery coronary artery bypass grafting, good cooperation with the clinical psychologist
排除标准
- •patients > 80 years old
- •cerebrovascular disease with residual deficits
- •alcoholism
- •psychiatric disease
结局指标
主要结局
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data
时间窗: September 2010
次要结局
- better neurocognitive outcome in Erythromycin group(November 2010)
研究者
Evanthia Thomaidou
Consultant Anesthesiologist
AHEPA University Hospital