跳至主要内容
临床试验/NCT04028102
NCT04028102Unknown不适用

Optimization of Initial Fluid Challenge by Cardiac and Lung Ultrasound in Patients With Sepsis

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
concordance of fluid volume

研究概览

简要总结

Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.

详细描述

Initial sepsis treatment requires fluid challenge (FC). While the Surviving Sepsis Campaign (SSC) indicates a fixed 30 ml/kg volume, there is concerns on the efficacy and safety of this volume.

Actually, the required volume is highly dependent of cardiac and pulmonary comorbidities, infection focus localization and intensity. The importance of the initial volume is crucial: if too low, it could not restore the hemodynamic status, if too high, it could induce a lung edema responsible for an increased morbidity and mortality.

Cardiac Ultrasound (US) has demonstrated its efficacy to approach cardiac output by measuring the velocity-time integral (VTI) in the aortic chamber and its variations induced by the FC. While the VTI induced variation by a 500-ml FC in 20 min is above 10%, the patient is still fluid responsiveness and FC has to be continued. Conversely, when the variation is below 10%, FC has to be stopped.

Lung Ultrasound can detect a sub-clinical pulmonary edema before oxygenation degradation by visualization of diffuses B lines. The combination of both techniques is thus able to individualize the actual needed FC volume.

In patients with sepsis as defined by SEPSIS-3 and with hypotension (MAP < 65 mm Hg or lactate > 2 mmol/l), the FC of saline serum is individualized by the US technique. The volume is compared with the fixed 30 ml/kg.

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

  • patients >18 years old with sepsis as defined by SEPSIS-3 and with hypotension (MAP < 65 mm Hg or lactate > 2 mmol/l)

排除标准

  • documented end-of-life
  • pregnancy
  • B/B initial profile to the first Lung US

结局指标

主要结局

concordance of fluid volume

时间窗: 3 hours after FC initiation

number of patients with delta FC volume \> 20% between US technique and the theoretical 30 ml/kg

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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