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临床试验/NCT03922178
NCT03922178已完成不适用

Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation

Pierre Wauthy2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
2
主要终点
Tele-systolic volume of the left ventricle

研究概览

简要总结

The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself.

Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period.

The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively.

The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported.

The objectives of this study are:

  • To characterize the left ventricular diastolic failure after withdrawal of the extracorporeal circulation in coronary surgery.
  • To identify the kinetics of this early diastolic failure after withdrawal of the extracorporeal circulation.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient of the CHU Brugmann Hospital receiving elective coronary surgery.
  • Patient in sinusal rhythm before the operation and during the collection of hemodynamic data.
  • Patients with conserved left ventricular function (based on left ventricular ejection fraction assessed by preoperative echocardiography and superior to 50%)

排除标准

  • Hypertrophic cardiomyopathy (diastolic septal thickness> 15 mm)
  • Heart failure with left ventricular ejection fraction <50%
  • Presence of cardiac valvulopathy, concerning both right and left atrio-ventricular and ventriculo-arterial valves
  • Presence of valvular prosthesis
  • Congenital heart disease
  • Pregnancy
  • Participation to another clinical study

结局指标

主要结局

Tele-systolic volume of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.

Tele-systolic pressure of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.

Diastolic pressure of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.

Diastolic volume of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.

Ejection volume of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.

Contractility index of the left ventricle

时间窗: 20 minutes after extracorporeal circulation is stopped

Computed by the following formula: (dP/dt max)/P

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Medical Director of the CHU Brugmann Hospital

Brugmann University Hospital

研究点 (2)

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