此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Myocardial Work in Septic Shock Patients (MYWORKSS)

2021年12月3日 更新者:Humanitas Clinical and Research Center

Myocardial Work in Septic Shock Patients: an Observational Study

Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics, adding information on cardiac performance when compared with traditional parameters of left ventricle (LV) systolic function, such as ejection fraction (EF).

However, their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload.

Myocardial work (MW) is emerging as an alternative tool for studying LV myocardial systolic function, because it incorporates both deformation and load into its analysis.

The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints. Secondarily, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.

研究概览

地位

尚未招聘

详细说明

Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics, adding information on cardiac performance when compared with traditional parameters of left ventricle (LV) systolic function, such as ejection fraction (EF).

However, their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload.

Myocardial work (MW) is emerging as an alternative tool for studying LV myocardial systolic function, because it incorporates both deformation and load into its analysis. In this context, MW could be considered as an advancement of myocardial strain, allowing to investigate LV performance also in cases of changes in afterload that could lead to misleading conclusions if relying only on strain analysis.

Conditions of increased afterload can in fact negatively impact on myocardial strain even if MWis normal. MW assessment was initially calculated using invasive pressure measurements, which limited its widespread use in clinical practice.

Recently, Russell et al. demonstrated that pressure-strain loops (PSLs) could estimate LV performance in a non-invasive manner, deriving LV pressure (LVP) curves from non-invasively acquired brachial artery cuff pressure. To date, the technique has been applied in myocardial ischaemia and in identification of cardiac resynchronization therapy (CRT)-responders with good results.

This clinical approach has been never tested, insofar, septic shock patients. The heart is one of the organs most frequently failing in sepsis; however, depending on the definition used, the prevalence of sepsis-induced cardiac dysfunction may vary between 10% and 70%. The sepsis-induced dysregulated inflammatory response has been directly linked to cardiomyocyte dysfunction, leading to a broad spectrum of cardiomyopathies, including ventricles' impairment during systole or diastole, inadequate cardiac output, oxygen delivery, or primary myocardial cellular injury.

Hence, in septic shocked patients, echocardiography plays a pivotal role, identifying most of the clinical cardiac patterns related to acute systolic dysfunction and chambers' dilation using basic level 2D and M-mode echocardiography. A more comprehensive diagnosis can be achieved with advanced levels of competency. Simultaneously, hemodynamic evaluation and monitoring are possible with advanced levels of competency, including the use of color Doppler, spectral Doppler, tissue Doppler imaging, and, eventually, 3D or speckled tracking. Specific pathways can now achieve all these steps of competence for skills certification, developed by intensive care medicine societies.

A variety of cardiac changes can be associated with septic shock, although a normal study is not unusual [7]. Abnormalities in LVEF (i.e., contractile impairment may be associated with either a global dysfunction or exhibited as specific patterns with apical akinesis and ballooning accompanied by good basal LV contraction and is almost always reversible over days), LV diastolic function, and right ventricular (RV) function have all been described. Since the resuscitation in septic shock is mainly focused on an aggressive and rapid fluid resuscitation associated with the administration of systemic vasopressors to optimize cardiac preload, output, and peripheral perfusion, the assessment of the basal cardiac function is critical and should be routinely performed at the bedside for this purpose.

The dynamic interaction between the heart and the systemic circulation allows the cardiovascular system to be efficient in providing adequate cardiac output and arterial pressures necessary for sufficient organ perfusion. The cardiovascular system provides adequate pressure and flow to the peripheral organs in different physiological and pathological conditions because of the continuous modulation of the arterial system compliance, stiffness and resistance with respect to LV systolic performance. This challenging interplay may lead to a condition called "ventriculo-arterial uncoupling", when the ration between myocardial performance and peripheral response (Ea/Ees) is unbalanced. The hemodynamic profile of septic shock is primarily characterized by generalized vasodilatation resulting in severe hypotension with systemic hypoperfusion. In most of the patients with septic shock, cardiovascular efficiency is impaired, and the Ea/Ees becomes uncoupled (Ea/Ees > 1). Th e hemodynamic profile is characterized by both the significant increase in Ea and the decrease in Ees. Because the increase in Ea is generally induced by pharmacological vasoconstriction. (norepinephrine) and the consequent increase in arterial tone, a decrease in Ees generally depends on the reduction in myocardial contractility. Whatever the underlying mechanism, when A-V uncoupling occurs in septic shock, the cardiac energetics are unfavorable and are often sacrificed to maintain tissue perfusion.

The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints. Secondarily, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.

研究类型

观察性的

注册 (预期的)

45

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Milan
      • Rozzano、Milan、意大利、20089
        • Humanitas Clinical and Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with diagnosis of septic shock < 24h and acute circulatory failure was defined as at least one of the following criteria:

  • Systolic arterial pressure ≤ 90 mmHg (or a decrease > 50 mm Hg in hypertensive patients) or a mean arterial pressure (MAP) ≤ 70 mmHg or the use of vasopressors to maintain SAP > 90 mmHg.
  • skin mottling
  • tachycardia ≥100 beats/min
  • urinary flow ≤ 0.5 mL/kg for at least 2 hours
  • blood lactate level ≥ 2 mmol/L.

描述

Inclusion criteria:

  • Expected to be ventilated for > 48 hours
  • Age > 50

Exclusion criteria:

  • Atrial fibrillation (at the admission or during intensive care unit stay);
  • Neuromuscular disorders;
  • Home ventilation prior to admission;
  • Palliative intubation;
  • Intubation for an indication to tracheostomy;
  • Poor acoustic window (after the first assessment);
  • Severe mitral and/or aortic valve stenosis or regurgitation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Septic Shock Patients
Patients admitted with diagnosis of septic shock
Myocardial work (MW) is emerging as an alternative tool for studying LV myocardial systolic function, because it incorporates both deformation and load into its analysis. In this context, MW could be considered as an advancement of myocardial strain, allowing to investigate LV performance also in cases of changes in afterload that could lead to misleading conclusions if relying only on strain analysis. This parameter will be evaluated by using an echographer equipped with a specific software for the analysis (Ecog Vivid E95 Ultra GE®)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Myocardial Work
大体时间:24h from intensive care unit admission
Quantification of Myocardial Work Index
24h from intensive care unit admission

次要结果测量

结果测量
措施说明
大体时间
Myocardial Work
大体时间:60 +/- 12 h from intensive care unit admission
Quantification of Myocardial Work Index
60 +/- 12 h from intensive care unit admission
Myocardial Work
大体时间:7 days from intensive care unit admission
Quantification of Myocardial Work Index
7 days from intensive care unit admission

其他结果措施

结果测量
措施说明
大体时间
Myocardial Work
大体时间:1h from norephinefrine infusion start
Quantification of Myocardial Work Index
1h from norephinefrine infusion start
Myocardial Work
大体时间:1h from norephinefrine infusion dose increase
Quantification of Myocardial Work Index
1h from norephinefrine infusion dose increase
Myocardial Work
大体时间:6h from norephinefrine infusion dose increase
Quantification of Myocardial Work Index
6h from norephinefrine infusion dose increase
Myocardial Work
大体时间:1h from dobutamine infusion start
Quantification of Myocardial Work Index
1h from dobutamine infusion start

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年1月1日

初级完成 (预期的)

2023年1月1日

研究完成 (预期的)

2023年1月1日

研究注册日期

首次提交

2021年12月3日

首先提交符合 QC 标准的

2021年12月3日

首次发布 (实际的)

2021年12月15日

研究记录更新

最后更新发布 (实际的)

2021年12月15日

上次提交的符合 QC 标准的更新

2021年12月3日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Myocardial Work的临床试验

3
订阅