Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value
研究概览
简要总结
Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.
详细描述
Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.
Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
anesthesiologist who performed TEE measurements and who was responsible for data collection will be blinded to patient group allocation
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status II & III
- •Age between 18 and 70 years
- •Both Gender
- •Body mass index less than 40 kg/m2
- •Ejection fraction of >40%
- •Tricuspid annular plane systolic excursion (TAPSE) < 1.7cm
排除标准
- •Patient refusal.
- •Preoperative RV impairment
- •Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)
- •Patients with any contraindications to Transesophageal echocardiography (TEE)
- •Redo or Re-exploration surgery
- •Patients with chronic kidney disease (serum creatinine > 1.5 mg/ dl)
- •Patients with chronic liver disease (child pugh B and C)
研究组 & 干预措施
Epinephrine group (group E)
The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping
干预措施: Epinephrine (Drug)
Milrinone group (group M)
patients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping
干预措施: Milrinone Injection (Drug)
结局指标
主要结局
The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value
时间窗: Basal then within 5 mins post-cardiopulmonary bypass
measured by Transesophageal echocardiography (TEE)
次要结局
- Vasoactive-Inotrope Score (VIS)(recorded at 6, 12, 24, and 48 hours postoperative)
- Total consumption doses of Vasopressors(48 hours postoperative)
- Tricuspid annular plane systolic excursion (TAPSE)(within 30-60 minutes post-cardiopulmonary bypass)
- Incidence of Right Ventricular Dysfunction after Cardiac Surgery(24 hours postoperative)
- Incidence of Arrhythmias(intraoperatively and 24 hours postoperative)
研究者
maha abou-zeid
Professor of Anesthesia , surgical Intensive care and pain management Faculty of Medicine
Mansoura University
