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临床试验/NCT05538637
NCT05538637已完成不适用

Reliability and Accuracy of Mitral Velocity Time-integral Variability With Passive Leg Raising as a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure in the ICU.

Avicenna Military Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月6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
50
试验地点
1
主要终点
Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness

研究概览

简要总结

The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.

详细描述

Adult patients with acute circulatory failure will be included in the study. An initial echocardiography is performed in patients placed in a semi-recumbent position. On the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (LVOT-VTI) and mitral valve (MV-VTI) velocity time integral are measured (baseline values). Then a passive leg raise test is performed and the parameters (LVOT-VTI and MV-VTI) are measured again. Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10%. In preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. Immediately after fluid therapy, the same parameters are recorded during a third echocardiography. An increase of 10% or more of LVOT-VTI , compared with baseline, defines fluid responsiveness. Patients are monitored using the standard of care practices. Hemodynamic assessment includes repetitive echocardiographic examinations if needed. In patients with shock, invasive blood pressure is monitored with an arterial catheter.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Acute circulatory failure.

排除标准

  • Recent surgery (<5 days)
  • Suspected or confirmed intra-abdominal hypertension.
  • Intracranial hypertension.
  • Severe mitral valve disease: Severe mitral insufficiency or severe mitral stenosis
  • Acute cor pulmonale
  • Atrial fibrillation
  • Low echogenicity

结局指标

主要结局

Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate preload-responsiveness

时间窗: through study completion, an average of 6 months

Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after passive leg raising) to discriminate preload-responsive patients.

Reliability and accuracy of the change in mitral valve velocity time-integral (cm) to discriminate fluid-responsiveness

时间窗: through study completion, an average of 6 months

Reliability and accuracy of the change in mitral valve velocity time-integral (cm) measured by echocardiography (before and after fluid loading with 500 ml of saline) to discriminate fluid-responsive patients.

次要结局

未报告次要终点

研究者

发起方
Avicenna Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Younes Aissaoui, MD

Professor of Anesthesiology and Intensive Care Medicine - Head of surgical intensive care unit

Avicenna Military Hospital

研究点 (1)

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