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临床试验/NCT03595111
NCT03595111Unknown不适用

Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery

Assiut University0 个研究点目标入组 60 人开始时间: 2018年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Myocardial biopsy

研究概览

简要总结

Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

详细描述

Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

研究设计

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

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes.
  • Hemodynamic stability.

排除标准

  • Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

研究组 & 干预措施

Myocardial biopsy

Experimental

The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.

干预措施: myocardial biopsy (Procedure)

结局指标

主要结局

Myocardial biopsy

时间窗: within 24 hours

Myocardial cell edema either focal or diffuse was detected in histopathological examination

次要结局

  • The inotropic score(within one month)
  • Serum cardiac troponin level(first 24 hours)
  • 30-day mortality(30 days)
  • Type of cardiac rhythm on return(within 24 hours)

研究者

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

Sayed Kaoud Abd-Elshafy

Associate Profossor of Anesthesiology

Assiut University

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