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临床试验/NCT01144039
NCT01144039已完成4 期

Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
27
试验地点
2
主要终点
flow propagational velocity

研究概览

简要总结

Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy .

Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe aortic stenosis
  • left ventricular hypertrophy of more than 10mm IVS thickness
  • normal ejection fraction

排除标准

  • moderately or severely reduced systolic left ventricular function (ejection fraction <30%)
  • atrial fibrillation or flutter
  • intolerance to glutamate.

结局指标

主要结局

flow propagational velocity

Isovolumic relaxation time

E-velocity

A-velocity

E/A ratio

次要结局

  • ejection fraction
  • cardiac output
  • mitral ring motion

研究者

申办方类型
Other

研究点 (2)

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