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临床试验/NCT03621618
NCT03621618撤回不适用

Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
30
试验地点
2
主要终点
Change of Dynamic Arterial Elastance (Eadyn)

研究概览

简要总结

The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.

详细描述

Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.

Arterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.

Combined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - ICU patients, treated/supported with noradrenalin or dobutamine.

排除标准

  • Septic shock
  • Aortic valve regurgitation and defect of septum
  • Severe aortic sclerosis, aortic prosthesis
  • Severe hypertension (MAP > 130 mmHg)
  • Cardiac arrhythmia
  • Tachycardia with a heart rate higher than 150 bpm
  • Age below 18 or above 75 y
  • Patient height below 120 cm (48") or above 230 cm (90")
  • Patient weight less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
  • Intra-aortic balloon pump

结局指标

主要结局

Change of Dynamic Arterial Elastance (Eadyn)

时间窗: baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation

display on the hemodynamic monitor

次要结局

  • Eadyn estimation on haemodynamic monitor(from 30 to 90 minutes after increase with 20% of vasoactive medication)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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