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临床试验/NCT07144267
NCT07144267尚未招募不适用

Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial

Mansoura University0 个研究点目标入组 102 人开始时间: 2026年3月1日最近更新:
干预措施
相关药物

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

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)

Active Comparator

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)

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

maha abou-zeid

Professor of Anesthesia , surgical Intensive care and pain management Faculty of Medicine

Mansoura University

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