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Fluid Responsiveness Assessment in Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07073859
Acronym
FRAICHE
Enrollment
513
Registered
2025-07-18
Start date
2024-03-19
Completion date
2024-07-20
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory Failure, Shock State

Keywords

Circulatory failure, Fluid therapy, Fluid responsiveness, Critical care

Brief summary

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.

Detailed description

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.

Interventions

OTHERFluid expansion

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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of fluid expansions preceded by a fluid responsiveness assessmentDay 0It will be collected by auditing the prescribing physician after each fluid expansion administration.

Secondary

MeasureTime frame
Percentage of fluid responsiveness tests used with all of the validity criteriaDay 0
Mean volume of fluid expansionsDay 0
Mean duration of fluid expansionsDay 0
Percentage of fluid expansion efficacy evaluations based on cardiac output measurementDay 0
Association between fluid responsiveness assessment and prescribing physician's seniorityDay 0
Association between fluid responsiveness assessment and prescribing physician's specialtyDay 0
Percentage of each fluid responsiveness test usedDay 0
Association between fluid responsiveness assessment and origin of hemodynamic failureDay 0
Association between fluid responsiveness assessment and history of previous fluid expansionDay 0
Association between fluid responsiveness assessment and inotropic or vasopressor supportDay 0
Association between fluid responsiveness assessment and strict criteria for acute circulatory failureDay 0
Association between fluid responsiveness assessment and volume of fluid expansionDay 0
Association between fluid responsiveness assessment and fluid administered.Day 0
Association between fluid responsiveness assessment and patient's ageDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026