跳至主要内容
临床试验/NCT06415916
NCT06415916招募中不适用

Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit : FLUID-REACT Study

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
the variation in the VExUs score during passive leg raising

研究概览

简要总结

A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction. The standard treatment, including volume expansion and vasopressor/inotropic agents, often leads to water and sodium overload, increasing the risk of morbidity and mortality in the ICU. The combination of this overload and myocardial dysfunction lead to venous congestion, particularly affecting the lungs, kidneys and gastrointestinal system. Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload. Fluid tolerance, defined as a patient's ability to tolerate additional volumes of solutes without adverse effects, is assessed retrospectively by clinical signs (capillary refill time, oedema, hepatojugular reflux, etc.) and ultrasound scores (VExUS score, LUS score, etc.). However, these indicators do not fully reflect the complexity of venous congestion in patients with various conditions.

Assessing fluid tolerance remains a challenge in clinical practice. It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling. Despite their common use, there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance.

In conclusion, the main hypothesis is that changes in ultrasound congestion parameters (VExUS score, LUS score and others) during passive leg raising could predict a patient's subsequent tolerance to volume expander.

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

  • Adult patient
  • Patient who has provided non-opposition (or health proxy or a close relative if unable to receive the information)
  • Patient admitted to intensive care and requiring volume expander

排除标准

  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • Pregnant, parturient or breast-feeding women
  • Poor echogenicity assessed by the operator
  • Chronic AC/FA
  • Mechanical cardiac assistance

研究组 & 干预措施

patient

Patients admitted to intensive care who require volume expander

干预措施: Cardiac ultrasound (Procedure)

patient

Patients admitted to intensive care who require volume expander

干预措施: Lung ultrasound (Procedure)

结局指标

主要结局

the variation in the VExUs score during passive leg raising

时间窗: Through study completion, on average of 2 hours

The VExUS score is calculated from ultrasound-doppler measurements of the inferior vena cava (IVC), suprahepatic venous flow (S wave, D wave), portal flow (continuous, pulsatile \>30%, pulsatile \>50%), renal venous flow (continuous, pulsatile biphasic, pulsatile monophasic). It is graded from 0 to 3

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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