Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Coronary sinus lactate level immediately before declamping the aorta.
研究概览
简要总结
Perioperative myocardial injury remains one of the most serious complications of cardiac surgery.
Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest.
Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle.
In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic.
Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-50 years old patients, with either sex with solitary valvular disease
排除标准
- •• Myocardial infarction within 2 weeks.
- •History of reaction or toxicity to esmolol or other beta blockers.
- •New York Heart Association class IV congestive heart failure despite treatment.
- •Persistent hypotension (systolic blood pressure <80 mm Hg).
- •severe pulmonary hypertension
- •Ejection fraction less than 45%
- •Patients with coronary artery disease
- •Patients with congenital heart disease
- •Patients with previous cardiac surgery
- •Patients with liver disease (child class B and C)
- •Patients with second or third degree heart block
- •Patients having resting heart rate less than 50 ppm
- •Patients using calcium channel blockers
研究组 & 干预措施
Control
干预措施: Potassium Cardioplegic Solution (Drug)
Esmolol
干预措施: Esmolol (Drug)
Esmolol
干预措施: Potassium Cardioplegic Solution (Drug)
结局指标
主要结局
Coronary sinus lactate level immediately before declamping the aorta.
时间窗: 1 hour during declamping
the lactate from the coronary sinus
次要结局
未报告次要终点
研究者
Ayman Abougabal
Consultant
Kasr El Aini Hospital