Circulatory FailureFRAICHENCT07073859
Fluid Responsiveness Assessment in Children
An observational study of Circulatory Failure and Shock State, run by University Hospital, Bordeaux at 31 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 weeks to 15 years
- Conditions the study is for
- Circulatory Failure, Shock State
- What is being tested?
- Fluid expansion
- How many people
- 513 participants
- Where
- 31 sitesFrance
- Study dates
- 19 Mar 2024to 20 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Fluid expansion prescriptions in pediatric ICU (PICU)
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Site Sud - CHU d'Amiens Picardie
Amiens, France, 80054
CHU d'Angers
Angers, France, 49933
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
Hôpital Morvan - CHU de Brest
Brest, France, 29200
Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, France, 69500
CHU Caen Normandie
Caen, France, 14000
Site Estaing - CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63100
Hôpital d'Enfants - CHU de Dijon-Bourgogne
Dijon, France, 21000
Hôpital Raymond Poincaré - Assistance Publique - Hôpitaux de Paris
Garches, France, 92380
Hôpital Couple-Enfant -Hôpital Couple-Enfant
Grenoble, France, 38043
Hôpital Felix Guyon (Saint Denis) - CHU de la Réunion
La Réunion, France, 97400
Hôpital Kremlin Bicêtre - Assistance Publique - Hôpitaux de Paris
Le Kremlin-Bicêtre, France, 94270
Hôpital Marie-Lannelongue
Le Plessis-Robinson, France, 92350
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France, 59000
Hôpital de la mère et de l'enfant - CHU de Limoges
Limoges, France, 87042
Hôpital de la Timone - Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13385
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France, 34295
Hôpital mère-enfant - CHU de Nantes
Nantes, France, 44093
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France, 06200
Hôpital Trousseau - Assistance Publique - Hôpitaux de Paris
Paris, France, 75012
Hôpital Necker-Enfants Malades - Assistance Publique - Hôpitaux de Paris
Paris, France, 75015
Hôpital Robert Debré - Assistance Publique - Hôpitaux de Paris
Paris, France, 75019
CHU de Bordeaux - Hôpital Cardiologique Haut-Lévêque
Pessac, France, 33604
La Milétrie - CHU de Poitiers
Poitiers, France, 86000
Hôpital d'enfants - American Memorial Hospital - CHU de Reims
Reims, France, 51100
Hôpital Sud - CHU de Rennes
Rennes, France, 35033
Hôpital Charles-Nicolle - CHU de Rouen
Rouen, France, 76000
Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Hôpital des enfants - Hôpital des enfants
Toulouse, France, 31300
Hôpital Clocheville - CHRU de Tours
Tours, France, 37000
Hôpitaux de Brabois - CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500
About this study
Official title: Fluid Responsiveness Assessment in Pediatric Intensive Care Units: a Nationwide Clinical Practice Analysis
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.
Read the 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.
- Conditions
- Circulatory Failure, Shock State
- Being tested
- Fluid expansion
- Keywords
- Circulatory failure, Fluid therapy, Fluid responsiveness, Critical care
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid expansionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of fluid expansions preceded by a fluid responsiveness assessment
It will be collected by auditing the prescribing physician after each fluid expansion administration.
Measured: Day 0
Secondary outcomes (14)
Percentage of each fluid responsiveness test used
Measured: Day 0
Percentage of fluid responsiveness tests used with all of the validity criteria
Measured: Day 0
Mean volume of fluid expansions
Measured: Day 0
Mean duration of fluid expansions
Measured: Day 0
Percentage of fluid expansion efficacy evaluations based on cardiac output measurement
Measured: Day 0
Association between fluid responsiveness assessment and prescribing physician's seniority
Measured: Day 0
Association between fluid responsiveness assessment and prescribing physician's specialty
Measured: Day 0
Association between fluid responsiveness assessment and patient's age
Measured: Day 0
Association between fluid responsiveness assessment and origin of hemodynamic failure
Measured: Day 0
Association between fluid responsiveness assessment and history of previous fluid expansion
Measured: Day 0
Association between fluid responsiveness assessment and inotropic or vasopressor support
Measured: Day 0
Association between fluid responsiveness assessment and strict criteria for acute circulatory failure
Measured: Day 0
Association between fluid responsiveness assessment and volume of fluid expansion
Measured: Day 0
Association between fluid responsiveness assessment and fluid administered.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start19 Mar 2024
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 513 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073859
- Sponsor's protocol ID
- CHUBX 2023/94
- Other IDs
- CER-BDX 2024 - 31
- Acronym
- FRAICHE
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Assessment in Pediatric Intensive Care Units: a Nationwide Clinical Practice Analysis
- ClinicalTrials.gov ID
- NCT07073859
- Acronym / sponsor ID
- FRAICHE / CHUBX 2023/94
- Conditions
- Circulatory Failure, Shock State
- Keywords
- Circulatory failure, Fluid therapy, Fluid responsiveness, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 37 weeks to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Fluid expansion prescriptions in pediatric ICU (PICU)
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid expansionData 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. | Other | – |
Primary outcome
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.
14 secondary outcomes
Percentage of each fluid responsiveness test used
Time frame: Day 0
Percentage of fluid responsiveness tests used with all of the validity criteria
Time frame: Day 0
Mean volume of fluid expansions
Time frame: Day 0
Mean duration of fluid expansions
Time frame: Day 0
Percentage of fluid expansion efficacy evaluations based on cardiac output measurement
Time frame: Day 0
Association between fluid responsiveness assessment and prescribing physician's seniority
Time frame: Day 0
Association between fluid responsiveness assessment and prescribing physician's specialty
Time frame: Day 0
Association between fluid responsiveness assessment and patient's age
Time frame: Day 0
Association between fluid responsiveness assessment and origin of hemodynamic failure
Time frame: Day 0
Association between fluid responsiveness assessment and history of previous fluid expansion
Time frame: Day 0
Association between fluid responsiveness assessment and inotropic or vasopressor support
Time frame: Day 0
Association between fluid responsiveness assessment and strict criteria for acute circulatory failure
Time frame: Day 0
Association between fluid responsiveness assessment and volume of fluid expansion
Time frame: Day 0
Association between fluid responsiveness assessment and fluid administered.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Failure and Shock State, run by University Hospital, Bordeaux at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of fluid expansions preceded by a fluid responsiveness assessment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.