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