Circulatory Failure (Shock)FLOWNCT07494643
Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
A study testing Echocardiographic in people with Circulatory Failure (Shock), run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
In this study of diagnostic accuracy, the investigators aim to validate a fluid-responsiveness test in critically ill children mechanically ventilated with low tidal volume. This test is the famous respiratory variability of peak aortic velocity (ΔVPeak), which is based on cardiopulmonary interactions but is only… Read more about this study
- Who is it for?
- Ages 0 days to 15 years
- Conditions the study is for
- Circulatory Failure (Shock)
- What is being tested?
- Echocardiographic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Nov 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 0 days and 15 years old
- Patient hospitalized in a pediatric intensive care unit.
- Prescription of a 10ml/kg (±20%) fluid expansion by the physician in charge, as a standard care treatment of circulatory failure (precise indication is up to the physician in charge).
- Mechanical ventilation
- Tidal volume < 6ml/kg (±15%)
- Fluid responsiveness echocardiographic assessment as of routine care
Who cannot join
- Prematurity (corrected gestational age bellow 37 weeks)
- Arythmia
- Hemodynamic instability making dangerous the delay necessary for any measurement.
- Prone position
- Impairment of echocardiographic acoustic window
- Extracorporeal membrane oxygenation
Show all 14Show fewer
- Respiratory rate (measured) > 60 cycles per minute (including high frequency oscillation)
- Significant breathing movements (high work of breathing, clinically assessed)
- Restlessness with desynchronization patient/ventilator
- Open chest
- Cardiogenic pulmonary oedema
- Known intracardiac or vascular shunt
- Known hemodynamically significant valvopathy
- Opposition to participate expressed by the patient or by a parent or legal guardian
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU d'Amiens Picardie
Amiens
Ghida GHOSTINE, MD, 0322087604 ext. +33, Ghostine.Ghida@chu-amiens.fr
- Recruiting
CHU de BORDEAUX
Bordeaux
Julien GOTCHAC, MD, 0556795913 ext. +33, julien.gotchac@chu-bordeaux.fr
Julien GOTCHAC, MD
- Recruiting
CHU de LIMOGES
Limoges
Adeline BERENGER, MD, 0555058666 ext. +33, adeline.berenger@chu-limoges.fr
- Recruiting
Hôpital Necker-Enfants Malades
Paris
Agathe BERANGER, MD, 0171196075 ext. +33, agathe.beranger@aphp.fr
- Recruiting
Hôpital Robert Debré
Paris
Julian SAN GEROTEO, MD, 0140032000 ext. +33, julian.san-geroteo@aphp.fr
- Recruiting
CHU de Rouen Normandie
Rouen
Cloé GUILBERT, MD, 0232888990 ext. +33, Cloe.Guilbert@chu-rouen.fr
About this study
In this study of diagnostic accuracy, the investigators aim to validate a fluid-responsiveness test in critically ill children mechanically ventilated with low tidal volume. This test is the famous respiratory variability of peak aortic velocity (ΔVPeak), which is based on cardiopulmonary interactions but is only validated in mechanically ventilated children with a tidal volume of at least 8ml/kg, which is uncommon nowadays. This would help physicians to identify children ventilated with low tidal volume and suffering from acute circulatory failure that could benefit from a volume expansion, thus avoiding a potentially useless or even dangerous fluid expansion that could lead to fluid overload.
To this end, the diagnostic accuracy of ΔVPeak to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured in mechanically ventilated children with low tidal volume and requiring fluid bolus.
Read the detailed description
Volume expansion is the cornerstone of acute circulatory failure treatment in children. However, inappropriate administration can lead to fluid overload, which is associated with poor outcome. Thus, the search for indicators to predict fluid responsiveness is a major issue in pediatric intensive care unit. In such an emergency context, this assessment must be as simple and fast as possible, and ideally non-invasive. In children, ΔVPeak is the most used and studied test and has an excellent diagnostic accuracy. Moreover, this echocardiography-based test is noninvasive and easy to perform. Unfortunately, this test is only validated in children ventilated with tidal volume of at least 8ml/kg, a rare situation in practice. However, some recent data in both adults and preterm neonates suggest that fluid responsiveness tests based on cardiopulmonary interactions could be used even in patients on protective ventilation. Yet, to date, the diagnostic accuracy of ΔVPeak has never been investigated in children on protective ventilation (low tidal volume), although it is now the most common ventilation strategy in pediatric intensive care units. Therefore, the investigators hypothesize that ΔVPeak is reliable to predict fluid responsiveness in children mechanically ventilated with 6ml/kg tidal volume.
Therefore, the investigatorswill evaluate the diagnostic accuracy of ΔVPeak in critically ill children mechanically ventilated with low tidal volume, and for whom the physician in charge prescribed a 10ml/kg volume expansion to treat circulatory failure. The index test will be ΔVPeak. Fluid responsiveness will be defined as a > 15% increase in echocardiographically-measured stroke volume between baseline and within one hour after fluid expansion (gold standard test).
In this non-interventional multicentric prospective study of diagnostic accuracy, children requiring a 10ml/kg volume expansion will be included. Volume expansion will be delayed for a few minutes (<3min) in order to complete the baseline echocardiogram with standardized measurements, but no supplemental blood test or invasive parameters will be collected. Another echocardiographic evaluation will be conducted within one hour after volume expansion. Patients will be follow-up until PICU discharge.
- Conditions
- Circulatory Failure (Shock)
- Being tested
- Echocardiographic
- Keywords
- echocardiography, fluid responsiveness, goal-directed fluid management, shock, volume expansion
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographicProcedure or surgery
Patients included in this study would have received volume expansion anyway, as the prescription of 10ml/kg volume expansion by the physician in charge is the main inclusion criterion. The purpose of this study is to evaluate the diagnostic accuracy of a fluid responsiveness test. To this end, patients will undergo echocardiographic assessments, which are non-invasive, non-radiative, well tolerated and commonly used in this population as a standard of care in our center. No additional blood test or invasive parameters will be collected be collected.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic accuracy of ΔVPeak | Experimental | Not described Receives: Procedure: Echocardiographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC curve (AUROC, percent) of ΔVPeak to diagnose fluid responsiveness
The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study:
- The index test is ΔVPeak at baseline = difference between maximal and minimal peak aortic velocity (m/s) during 5 cardiac cycles, divided by mean peak aortic velocity (m/s). Peak aortic velocity is measured by transthoracic echocardiography with pulsed-Doppler in the left ventricular outflow tract from an apical 5-chambers view.
- The condition is "fluid responsiveness"
- The gold-standard reference test to diagnose fluid responsiveness is a stroke volume (SV) increase of at least 15% between baseline and after volume expansion: ΔSV-VE > 15% = ((SV after volume expansion - SV at baseline) / SV at baseline) > 15%. SV (ml) will be measured by transthoracic echocardiography as the product of left ventricular outflow tract surface (cm², from a par
Measured: Baseline
Secondary outcomes (21)
AUROC (percent) of the following index test to diagnose fluid responsiveness
Respiratory variability of peak pulmonary velocity i.e. difference between maximal and minimal peak pulmonary velocity (m/s) during 6 cardiac cycles, divided by mean pulmonary aortic velocity (m/s). Peak pulmonary velocity is measured by transthoracic echocardiography with pulsed-Doppler in the right ventricular outflow tract from parasternal view.
Measured: Baseline
Influencing factors
AUROC of deltaVPeak to diagnose fluid responsiveness in the following subgroups:
- Age below 2 years
- Age between 2 and 5 years
- Age between 5 and 15 years
- Anormal right ventricle (defined as a right ventricle dilatation (i.e., basal right ventricle diameter superior to the basal left ventricle diameter) or dysfunction (i.e., a tricuspid annular plane systolic excursion value or as a S wave tissular doppler value at lateral tricuspid annulus below 2 standard deviations for age and body surface area))
- Spontaneous breathing (clinically defined)
- Altered pulmonary compliance (defined as a pulmonary compliance of less than 0.5ml/kg/cmH2O, measured with the ventilator)
- Pediatric cute respiratory distress syndrome (clinically defined as per international guidelines)
And comparison of thoses AUROC (using a De Long test)
Measured: Baseline
Poor respiratory tolerance
Association between the binary outcome "poor respiratory tolerance of volume expansion" (composite outcome defined as the presence of at least one of the following conditions at the Time Frame "Hours 4": clinically meaningful oxygenation worsening compared to baseline, measured with oxygen saturation related to oxygen intake (fraction of inspired oxygen, percent); clinically meaningful pulmonary compliance worsening compared to baseline, measured in ml/cmH2O with the ventilator; therapeutic incrementation for acute respiratory distress syndrome such as neuromuscular blockade, prone positioning, inhaled nitric oxid or extracorporeal membrane oxygenation) and the following baseline echocardiographic parameters:
- Right ventricle dilatation (binary variable, defined as basal right ventricle diameter superior to basal left ventricle diameter)
- Right ventricle systolic dysfunction (binary variable, defined as a tricuspid annular plane systolic excursion value or as a S wave tissul
Measured: Baseline , immediately after volume expansion
Proportion of patients in each age category, according to fluid responsiveness
- Categorical variable (age category: 0-2 years / 2-5 years / 5-15 years)
- Unit : percent of patients
Measured: Baseline
Sex, in patients with and without fluid responsiveness
- Binary variable (M/F)
- Unit: percent of patients
Measured: Baseline
Weight, in patients with and without fluid responsiveness
- Continuous variable
- Unit: kg
Measured: Baseline
Volume of fluid expansion in patients with and without fluid responsiveness
Volume of fluid expansion during the last 24 hours before inclusion
- Continuous variable
- Unit: ml
Measured: Baseline
Heart rate in patients with and without fluid responsiveness
- continuous variable
- Unit: bpm
Measured: Baseline
Arterial pressure in patients with and without fluid responsiveness
- continuous variable
- Unit: mmHg
Measured: Baseline
Urine in patients with and without fluid responsiveness
Urine output
- continuous variable
- Unit: ml/kg/h
Measured: Baseline,
Capillary refill time with and without fluid responsiveness
- continuous variable
- Unit: sec
Measured: Baseline
Mottling, in patients with and without fluid responsiveness
- Binary variable (yes/no)
- Unit: percent of patients
Measured: Baseline
fluid balance in patients with and without fluid responsiveness
Cumulative fluid balance since intensive care admission
- continuous variable
- Unit : ml
Measured: Baseline
PELODS2 score in patients with and without fluid responsiveness
- continuous variable
- Unit : n
Measured: Baseline
Inotropic Score in patients with and without fluid responsiveness
- continuous variable
- Unit : n
Measured: Baseline
Left ventricular ejection fraction in patients with and without fluid responsiveness
- continuous variable
- Unit : percentage
Measured: Baseline
venous pressure in patients with and without fluid responsiveness
- continuous variable
- Unit : mmHg
Measured: Baseline
Blood lactate in patients with and without fluid responsiveness
- continuous variable
- Unit : mmol/L
Measured: Baseline
Length of mechanical ventilation in patients with and without fluid responsiveness
- Continuous variable.
- Unit: days.
Measured: Day 28
length of stay in intensive care in patients with and without fluid responsiveness
- continuous variable
- Unit : days.
Measured: Day 28
Mortality in patients with and without fluid responsiveness
- Mortality: binary variable (yes/no)
- Unit: percent of patients
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory Failure (Shock)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494643
- Sponsor's protocol ID
- CHUBX 2025/059
- Acronym
- FLOW
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 7 Apr 2026
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.
- ClinicalTrials.gov ID
- NCT07494643
- Acronym / sponsor ID
- FLOW / CHUBX 2025/059
- Conditions
- Circulatory Failure (Shock)
- Keywords
- echocardiography, fluid responsiveness, goal-directed fluid management, shock, volume expansion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
In this study of diagnostic accuracy, the investigators aim to validate a fluid-responsiveness test in critically ill children mechanically ventilated with low tidal volume. This test is the famous respiratory variability of peak aortic velocity (ΔVPeak), which is based on cardiopulmonary interactions but is only validated in mechanically ventilated children with a tidal volume of at least 8ml/kg, which is uncommon nowadays. This would help physicians to identify children ventilated with low tidal volume and suffering from acute circulatory failure that could benefit from a volume expansion, thus avoiding a potentially useless or even dangerous fluid expansion that could lead to fluid overload.
To this end, the diagnostic accuracy of ΔVPeak to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured in mechanically ventilated children with low tidal volume and requiring fluid bolus.
Detailed description
Volume expansion is the cornerstone of acute circulatory failure treatment in children. However, inappropriate administration can lead to fluid overload, which is associated with poor outcome. Thus, the search for indicators to predict fluid responsiveness is a major issue in pediatric intensive care unit. In such an emergency context, this assessment must be as simple and fast as possible, and ideally non-invasive. In children, ΔVPeak is the most used and studied test and has an excellent diagnostic accuracy. Moreover, this echocardiography-based test is noninvasive and easy to perform. Unfortunately, this test is only validated in children ventilated with tidal volume of at least 8ml/kg, a rare situation in practice. However, some recent data in both adults and preterm neonates suggest that fluid responsiveness tests based on cardiopulmonary interactions could be used even in patients on protective ventilation. Yet, to date, the diagnostic accuracy of ΔVPeak has never been investigated in children on protective ventilation (low tidal volume), although it is now the most common ventilation strategy in pediatric intensive care units. Therefore, the investigators hypothesize that ΔVPeak is reliable to predict fluid responsiveness in children mechanically ventilated with 6ml/kg tidal volume.
Therefore, the investigatorswill evaluate the diagnostic accuracy of ΔVPeak in critically ill children mechanically ventilated with low tidal volume, and for whom the physician in charge prescribed a 10ml/kg volume expansion to treat circulatory failure. The index test will be ΔVPeak. Fluid responsiveness will be defined as a > 15% increase in echocardiographically-measured stroke volume between baseline and within one hour after fluid expansion (gold standard test).
In this non-interventional multicentric prospective study of diagnostic accuracy, children requiring a 10ml/kg volume expansion will be included. Volume expansion will be delayed for a few minutes (<3min) in order to complete the baseline echocardiogram with standardized measurements, but no supplemental blood test or invasive parameters will be collected. Another echocardiographic evaluation will be conducted within one hour after volume expansion. Patients will be follow-up until PICU discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic accuracy of ΔVPeak | Experimental | Procedure: Echocardiographic |
Who may qualify
- Ages
- 0 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 0 days and 15 years old
- Patient hospitalized in a pediatric intensive care unit.
- Prescription of a 10ml/kg (±20%) fluid expansion by the physician in charge, as a standard care treatment of circulatory failure (precise indication is up to the physician in charge).
- Mechanical ventilation
- Tidal volume < 6ml/kg (±15%)
Key exclusion criteria (14 listed)
- Prematurity (corrected gestational age bellow 37 weeks)
- Arythmia
- Hemodynamic instability making dangerous the delay necessary for any measurement.
- Prone position
- Impairment of echocardiographic acoustic window
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 |
|---|---|---|
| EchocardiographicPatients included in this study would have received volume expansion anyway, as the prescription of 10ml/kg volume expansion by the physician in charge is the main inclusion criterion. The purpose of this study is to evaluate the diagnostic accuracy of a fluid responsiveness test. To this end, patients will undergo echocardiographic assessments, which are non-invasive, non-radiative, well tolerated and commonly used in this population as a standard of care in our center. No additional blood test or invasive parameters will be collected be collected. | Procedure or surgery | Diagnostic accuracy of ΔVPeak |
Primary outcome
Area under the ROC curve (AUROC, percent) of ΔVPeak to diagnose fluid responsiveness
Time frame: Baseline
The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study: * The index test is ΔVPeak at baseline = difference between maximal and minimal peak aortic velocity (m/s) during 5 cardiac cycles, divided by mean peak aortic velocity (m/s). Peak aortic velocity is measured by transthoracic echocardiography with pulsed-Doppler in the left ventricular outflow tract from an apical 5-chambers view. * The condition is "fluid responsiveness" * The gold-standard reference test to diagnose fluid responsiveness is a stroke volume (SV) increase of at least 15% between baseline and after volume expansion: ΔSV-VE > 15% = ((SV after volume expansion - SV at baseline) / SV at baseline) > 15%. SV (ml) will be measured by transthoracic echocardiography as the product of left ventricular outflow tract surface (cm², from a par
21 secondary outcomes
AUROC (percent) of the following index test to diagnose fluid responsiveness
Time frame: Baseline
Influencing factors
Time frame: Baseline
Poor respiratory tolerance
Time frame: Baseline , immediately after volume expansion
Proportion of patients in each age category, according to fluid responsiveness
Time frame: Baseline
Sex, in patients with and without fluid responsiveness
Time frame: Baseline
Weight, in patients with and without fluid responsiveness
Time frame: Baseline
Volume of fluid expansion in patients with and without fluid responsiveness
Time frame: Baseline
Heart rate in patients with and without fluid responsiveness
Time frame: Baseline
Arterial pressure in patients with and without fluid responsiveness
Time frame: Baseline
Urine in patients with and without fluid responsiveness
Time frame: Baseline,
Capillary refill time with and without fluid responsiveness
Time frame: Baseline
Mottling, in patients with and without fluid responsiveness
Time frame: Baseline
fluid balance in patients with and without fluid responsiveness
Time frame: Baseline
PELODS2 score in patients with and without fluid responsiveness
Time frame: Baseline
Inotropic Score in patients with and without fluid responsiveness
Time frame: Baseline
Left ventricular ejection fraction in patients with and without fluid responsiveness
Time frame: Baseline
venous pressure in patients with and without fluid responsiveness
Time frame: Baseline
Blood lactate in patients with and without fluid responsiveness
Time frame: Baseline
Length of mechanical ventilation in patients with and without fluid responsiveness
Time frame: Day 28
length of stay in intensive care in patients with and without fluid responsiveness
Time frame: Day 28
Mortality in patients with and without fluid responsiveness
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiographic in people with Circulatory Failure (Shock), run by University Hospital, Bordeaux at 6 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien GOTCHAC, MD (0556795913 ext. +33, julien.gotchac@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve (AUROC, percent) of ΔVPeak to diagnose fluid responsiveness (time frame: Baseline). 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 7 Apr 2026.