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临床试验/NCT04745845
NCT04745845已完成不适用

The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Change in Cardiac Power

研究概览

简要总结

The study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.

详细描述

After being informed about the study 40 elective CABG patients with written informed consent will undergo assessment of their arterio-ventricular coupling postoperatively after coronary bypass graft surgery. Whilst still in deep general anesthesia on the CT ICU the study population will be assessed by echocardiographic examination (transthoracic and transesophageal), blood pressure tracing by arterial line, respiratory data and ECG in 4 different situations.

Initially the individual patient is either considered fluid responsive (SVV >13%) og non- responsive (SVV<13%) by using stroke volume variation assessed by echocardiography.

In case of fluid responsiveness a fluid bolus of 4ml/kg of crystalloid fluid is given until SVV drops below 13% and the patient can be considered as fluid NON responder.

Right afterwards the study patient is stabilized with a baseline dose of noradrenaline (NA) intravenously in a supine position (situation 1). Situation 2 will be a slight increase in NA dose stabilizing mean arterial pressure in a "baseline + 20mmHg" state. After reversing the NA dose back to base line level the patient is allowed a short period of rest to wean of drug effect (4-5 x t1/2, appr. 12min). Subsequently the patient is to be placed in a 20% semi upright position (Anti-Trendelenburg) causing an increase in fluid responsiveness (situation 3). Following a phase of equilibration the dose of NA is again titrated up to obtain a 20mmHg increase in mean arterial pressure (situation 4).

There will be logging of arterial pressure curve and VTI-tracing I LVOT simultaneously (ultrapower, uPWR) as well as calculation of energy delivery, cardiac power, oscillatory power and -fraction and both arterial and ventricular elastance in every of those 4 situations.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •elective coronary artery bypass graft surgery
  • •requirement for Noradrenaline/Norepinephrine

排除标准

  • •lack of informed consent
  • •patient unsuitable for mean arterial pressure (MAP) elevation of 20mmHg
  • •patient requiring different blood pressure range due to medical/surgical needs
  • •poor image quality due to patient factors

研究组 & 干预措施

Noradrenalin

Experimental

treatment with 2 different NA concentrations in 2 different states of fluid responsiveness

干预措施: Noradrenalin (Procedure)

结局指标

主要结局

Change in Cardiac Power

时间窗: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

Change in Cardiac Power in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total and Mean Cardiac Power (Watt) can be determined. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.

Change in Oscillatory Power Fraction

时间窗: within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery

Change in Oscillatory Power Fraction (OPF) in reaction to both different noradrenaline doses and states of fluid responsiveness. By logging invasive BP curve and tracing left ventricular outflow tract Velocity Time Integral (by echocardiography) simultaneously Total Cardiac Power (TCP, Watt) and Cardiac Power Output (CPO, Watt) can be determined. By subtracting CPO from TCP, OPF (in %) can be calculated. Examining the response to different NA doses relative to fluid responsiveness the effect of NA on arterio-ventricular coupling can be examined.

次要结局

  • Change in single beat ventricular elastance(within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery)
  • Change in single beat arterial elastance(within 30 minutes after having been stabilised on the cardiothoracic ICU after performed CABG surgery)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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