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临床试验/NCT01941420
NCT01941420已完成不适用

Comparison of Blood and Crystalloid Cardioplegia on Patients Operated With Significant Aortic Stenosis. A Prospective Randomized Study.

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
CK-MB, troponin-T

研究概览

简要总结

The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min. Adult patients with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study. This group of patients was chosen for two reasons. First, these patients have left ventricular hypertrophy making the myocardium vulnerable to ischemia, secondly the investigators wanted to avoid the possible confounding effect of ischemia found in patients with variable degrees of coronary artery disease. Therefore, patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.

详细描述

Objective

Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.

Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

CK-MB, troponin-T

时间窗: 72 hours

次要结局

  • cytokines under ischemia.(70 min)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjørn Braathen

med. doc

Oslo University Hospital

研究点 (1)

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