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临床试验/NCT06287372
NCT06287372已完成不适用

Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegic Solutions in Routine Coronary Artery Bypass Surgery

Damascus University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Changes in markers of myocardial injury

研究概览

简要总结

The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures.

详细描述

Twenty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study. Patients were excluded from this study if they had suffered from previous myocardial infarction, had reduced ejection fraction or were undergoing combined or repeated surgery. Patients were randomly assigned to undergo surgery using one of two methods for myocardial protection:

  • Group 1: Calafiore intermittent antegrade warm blood cardioplegia (consisting of normothermic pump blood, potassium chloride 2 mEq/ml and magnesium sulfate 50%). This cardioplegic solution was administered at 37 degrees C following application of the aortic cross-clamp and repeated after completion of each distal coronary anastomosis as described previously.
  • Group 2: Modified del Nido intermittent antegrade cold blood cardioplegic solution (consisting of 750 ml of lactated Ringer solution, 200 ml of pump blood, 13 ml of sodium bicarbonate 8.4%, 16 ml of mannitol 20%, 4 ml of magnesium sulfate 50%, 13 ml of lidocaine 2% and 13 ml of potassium chloride 2 mEq/ml). This solution was administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp, and repeated as a 500 ml bolus if cross-clamp time extended beyond 60 minutes (none of the patients in this study).

Each patient enrolled in the study gave a written informed consent for the publication of the study data, and the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee number 171 dated 13 April 2022

Collection of blood samples and myocardial biopsies Peripheral blood samples were collected immediately prior to surgery and at 4, 12, 24 and 48 hours postoperatively and were used for determination of blood concentrations of cardiac enzymes (CK-MB and troponin I).

Myocardial biopsies (4-14 mg wet weight) were taken using a Tru-cut needle from the apex of the left ventricle in every patient as follows:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study.

排除标准

  • Patients were excluded from this study if they had suffered from previous myocardial infarction, had reduced ejection fraction or were undergoing combined or repeated surgery.

结局指标

主要结局

Changes in markers of myocardial injury

时间窗: 4, 12, 24 and 48 hours postoperatively

Changes in release of myocardial CK-MB and troponin I

次要结局

  • Changes in myocardial amino acid concentrations(2-3 hours)

研究者

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

Mohammad Bashar Izzat

Professor

Damascus University

研究点 (1)

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