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临床试验/NCT05797090
NCT05797090已完成不适用

Comparative Study Between Conventional Crystalloid Cardioplegic Solution With Modified Del Nido Cardioplegia in Mitral Valve Regurgitation Surgery

mohamed1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
myocardial protection

研究概览

简要总结

Mitral valvuloplasty for correction of chronic mitral regurgitation carries a lower operative mortality and morbidity and improved long-term survival than does mitral valve replacement. Unfortunately, mitral valvuloplasty is not possible in all patients with chronic mitral regurgitation because of unfavorable pathology or lack of experience with this technique

详细描述

Cardioplegia is a fundamental component in providing heart protection, limiting metabolic activity and increasing the myocardium's capacity to resist ischemia for prolonged periods, thus being essential for good surgical outcomes.

Numerous cardioplegia solutions exist with different compositions to provide sufficient myocardial protection. However, there is no standard for the optimal or ideal composition and delivery technique. Cardioplegia solutions are crystalloid or blood-based solutions with various chemical compounds.

Despite improvements in myocardial protection, prosthetic valves, surgical techniques, and postoperative care, the operative mortality and morbidity of mitral valve replacement for chronic mitral regurgitation remains high in comparison with other commonly performed heart operations.

The timing of the administration of cardioplegia is extremely important in terms of preventing myocardial dysfunction. Conventional multidose cardioplegias should be repeatedly administered in every 15 to 20 min. Frequent interruption of the surgical process, even for a short time, before each cardioplegia delivery leads to a loss of time during open heart surgery, where time is extremely important, and disrupts the coherence of the operation and the surgical concentration.

Crystalloid cardioplegic solutions achieve cardioplegic arrest through inhibition of either fast-acting sodium channels or calcium-activated mechanisms. Hyperkalemia can be used to inhibit the fast-acting sodium channels as it is in the St.Thomas Hospital solution and its modifications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective Mitral regurge replacement Surgery with normal Coronaries

排除标准

  • Patients with chronic renal disease (previous medical diagnosis or serum creatinine greater than 1.5mg/dL)
  • Left ventricular ejection fraction less than 50%.
  • Previous cardiac surgery
  • Patient with BMI > 30
  • Severe psychiatric illness
  • Inability or unwillingness to give informed consent for participation

研究组 & 干预措施

crystalloid cardioplegia with modified del Nido cardioplegia

Experimental

To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.

干预措施: Crystalloid Cardioplegic solution (Drug)

结局指标

主要结局

myocardial protection

时间窗: from baseline to 24 hours after the operation

Number of Participants With myocardial protection through measurements of the serum levels of the cardiac enzymes just after operation

次要结局

未报告次要终点

研究者

发起方
mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mohamed

Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University

Azhar University

研究点 (1)

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