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临床试验/NCT07073859
NCT07073859已完成不适用

Fluid Responsiveness Assessment in Pediatric Intensive Care Units: a Nationwide Clinical Practice Analysis

University Hospital, Bordeaux31 个研究点 分布在 1 个国家目标入组 513 人开始时间: 2024年3月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
513
试验地点
31
主要终点
Percentage of fluid expansions preceded by a fluid responsiveness assessment

研究概览

简要总结

Fluid responsiveness assessment is a major issue in intensive care. Since fewer fluid responsiveness tests can be used children, fluid expansion prescriptions are often based on professional practices due to the absence of guidelines. This observational, cross-sectional, multicentric study is an evaluation of professional practices regarding fluid expansions in pediatric intensive care units. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.

详细描述

Fluid expansion is the cornerstone of acute circulatory failure treatment. Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion (leading to fluid overload). Currently, the search for indicators to predict fluid responsiveness is a major issue in intensive care units (ICU). These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. This assessment is necessary but must be as simple as possible in an emergency setting such as ICU. Although several fluid responsiveness tests are available in adults, they are underused in current practice. In children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Thus, fluid expansion prescriptions in pediatric ICU (PICU) are based on professional practices that are often heterogeneous due to the absence of evidence-based guidelines. An evaluation of professional practices is a first step towards standardizing practices.

This study is an evaluation of professional practices regarding fluid expansion in PICU. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.

We will conduct an observational, cross-sectional, multicentric study in French PICU. Data will be collected retrospectively, after fluid expansion administration, by the prescribing physician through a electronic CRF (RedCAP). These data will be collected from standard monitoring and/or from the patient's medical record. Data will therefore only be collected at a single point in time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
37 Weeks 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age less than or equal to 15 years old
  • Hospitalization in a pediatric intensive care unit
  • Prescription by the attending physician of a fluid expansion in order to increase cardiac output and restore the patient's circulatory function, which the physician has judged to be impaired. Fluid expansion is defined as a rapid intravenous infusion (<30min) of a high volume (>10ml/kg or 250ml) of an isotonic crystalloid solution, albumin, or fresh frozen plasma. The decision to administer a fluid expansion and the type of fluid administered are left to the discretion of the physician (current practice).

排除标准

  • Patient less than 37 weeks' corrected gestational age
  • Univentricular circulatory physiology
  • Mechanical circulatory support
  • Opposition of the patient or his/her parents or legal guardians to data collection

结局指标

主要结局

Percentage of fluid expansions preceded by a fluid responsiveness assessment

时间窗: Day 0

It will be collected by auditing the prescribing physician after each fluid expansion administration.

次要结局

  • Association between fluid responsiveness assessment and patient's age(Day 0)
  • Association between fluid responsiveness assessment and prescribing physician's specialty(Day 0)
  • Percentage of each fluid responsiveness test used(Day 0)
  • Percentage of fluid responsiveness tests used with all of the validity criteria(Day 0)
  • Mean volume of fluid expansions(Day 0)
  • Mean duration of fluid expansions(Day 0)
  • Percentage of fluid expansion efficacy evaluations based on cardiac output measurement(Day 0)
  • Association between fluid responsiveness assessment and prescribing physician's seniority(Day 0)
  • Association between fluid responsiveness assessment and origin of hemodynamic failure(Day 0)
  • Association between fluid responsiveness assessment and history of previous fluid expansion(Day 0)
  • Association between fluid responsiveness assessment and inotropic or vasopressor support(Day 0)
  • Association between fluid responsiveness assessment and strict criteria for acute circulatory failure(Day 0)
  • Association between fluid responsiveness assessment and volume of fluid expansion(Day 0)
  • Association between fluid responsiveness assessment and fluid administered.(Day 0)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (31)

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