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临床试验/NCT06572995
NCT06572995招募中不适用

Assessment of Intra-thoracic Water by Bio Reactance During Stabilization and Therapeutic De-escalation in Septic Shock: A Prospective, Multicenter, Observational Study

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Changes in daily body weight

研究概览

简要总结

In ICU, fluid challenge represents one of the cornerstones of hemodynamic care. However, fluid overload due to an excessive and/or inappropriate fluid administration could be associated with morbidity or mortality. Unfortunately, there is currently no continuous non-invasive devices to monitor fluid content at bedside. Bio reactance is a non-invasive, rapid and continuous technology developed in order to measure body fluid compartment. Monitoring devices functioning with such technology are promising to evaluate fluid overload in ICU.

详细描述

During the resuscitation phase of shock, fluid administration represents one of the cornerstones of care in order to increase cardiac output and improve microvascular blood flow. However, inappropriate fluid administration can increase tissue edema which compromises recovery after the resolution of shock state. Recently, Sakr et al. demonstrated that a higher fluid balance at 72 hours was associated with hospital mortality after septic shock. Furthermore, an administration of more than 5 liters of fluid during the first ICU stay was independently associated with an increase in mortality and hospital costs. Therefore, treating fluid removal appears to be a key component of the de-escalation phase of shock. Thus, all valuable parameters which potentially reflect tissue edema may help clinicians to individualized the necessity of fluid removal during the stabilization and de-escalation phase of shock. Among them, extra-vascular lung water (EVLW) measured with trans-pulmonary thermodilution is able to detect changes in thoracic fluid content but needs to be monitored invasively and only sequential values are recorded (each thermodilution measure). On the other hand, lung ultrasonography may help clinicians to assess fluid overload but its ability to quantify thoracic fluid content is difficult and subjective.

Bio reactance is a non-invasive, rapid and continuous method to measure body fluid compartment. All measures can be performed at bedside. Bio reactance monitoring devices allow measurement of hemodynamic parameters such as cardiac index or stroke volume but also Thoracic Fluid Content (TFC). TFC is measured through the changes in impedance of thoracic tissue to the electrical current. This parameter represents the whole fluid content in the thorax (intravascular, extravascular and intra-pleural). TFC has already been evaluated in several context. During hemodialysis, TFC is correlated to the amount of fluid removal and might help clinician to improve hemodialysis session management in ICU. In cardiac surgery, electrical impedance is correlated with changes in fluid balance. In ICU, TFC is able to predict a mechanical ventilation weaning failure with a moderate accuracy (AUC 0.69 [0.57 - 0.8], bet cut-off value > 50 k.Ω-1) in patients with moderate to severe alteration of left ventricular ejection fraction.

The main objective of the current study will evaluated correlation between thoracic fluid content (TFC) measurement and other valuable indices of fluid overload used at bedside. Secondary objectives will be to evaluate association between TFC and other clinical outcomes (organ dysfunction, mortality and quality of life after hospital living).

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (Age >18 years old)
  • Septic shock according to Sepsis-3 definition:
  • A suspected or confirmed infection
  • Persisting hypotension, despite adequate fluid resuscitation, requiring vasopressor to maintain a Mean Arterial Pressure (MAP) ≥ 65 mmHg
  • Lactate level > 2 mmol/l
  • Predictive ICU length of stay > 3 days

排除标准

  • Admission in ICU for more than 3 days
  • Refusal to participate
  • Moribund patients
  • Decision of therapeutic withdrawal

结局指标

主要结局

Changes in daily body weight

时间窗: Daily, during the first 10 days

Evaluation of correlation between daily body weight and thoracic fluid content

Changes in daily fluid balance

时间窗: Daily, during the first 10 days

Evaluation of correlation between fluid balance and thoracic fluid content

Changes in extra vascular lung water

时间窗: Daily, during the first 10 days

Evaluation of correlation between extra vascular lung water and thoracic fluid content

次要结局

  • Length of ICU stay(during ICU stay (up to 10 days))
  • Length of hospital stay(during hospital stay (up to 10 days))
  • Ventilator free days at Day 28(Day 28)
  • Mortality at Day 28(Day 28)
  • Short Form-12(3 months)
  • Percentage of patients who return at home(3 months)
  • Percentage of patients who have professional activities(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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