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Completed

NCT Number: NCT07073859

Fluid Responsiveness Assessment in Children

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.

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Key information

Age range

37 week–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Sud - CHU d'Amiens Picardie, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Fluid expansion

Other

Data will be collected retrospectively, after fluid expansion administration, by the prescribing physician through. 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.

Primary outcomes

  1. Percentage of fluid expansions preceded by a fluid responsiveness assessment

    Time frame: Day 0

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

Secondary outcomes

  1. Percentage of each fluid responsiveness test used

    Time frame: Day 0

  2. Percentage of fluid responsiveness tests used with all of the validity criteria

    Time frame: Day 0

  3. Mean volume of fluid expansions

    Time frame: Day 0

  4. Mean duration of fluid expansions

    Time frame: Day 0

  5. Percentage of fluid expansion efficacy evaluations based on cardiac output measurement

    Time frame: Day 0

  6. Association between fluid responsiveness assessment and prescribing physician's seniority

    Time frame: Day 0

  7. Association between fluid responsiveness assessment and prescribing physician's specialty

    Time frame: Day 0

  8. Association between fluid responsiveness assessment and patient's age

    Time frame: Day 0

  9. Association between fluid responsiveness assessment and origin of hemodynamic failure

    Time frame: Day 0

  10. Association between fluid responsiveness assessment and history of previous fluid expansion

    Time frame: Day 0

  11. Association between fluid responsiveness assessment and inotropic or vasopressor support

    Time frame: Day 0

  12. Association between fluid responsiveness assessment and strict criteria for acute circulatory failure

    Time frame: Day 0

  13. Association between fluid responsiveness assessment and volume of fluid expansion

    Time frame: Day 0

  14. Association between fluid responsiveness assessment and fluid administered.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: FRAICHE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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