Circulatory Failure (Shock)FRENCHNCT05919719
Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren
An observational study of Circulatory Failure (Shock), run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. Read more about this study
- Who is it for?
- Ages 1 minute to 14 years
- Conditions the study is for
- Circulatory Failure (Shock)
- What is being tested?
- Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 1 Feb 2023
- 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 1 minute to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: At least 24 fluid expansion are needed, in 10 to 24 patients (maximum of 3 fluid expansion per patient). The "number needed to treat" was calculated with Obuchowski method, with an aphla risk of 0.05, a statistical power of 80%, a ratio "responder/nonresponder" of 1:1, and a predicted area under the receiver operating characteristic curve of 0.78 (based on previous studies). In order to be clinically relevant, since a large majority of patients admitted to our PICU are under 2 years of age, the investigators plan to include 24 fluid expansions administrated to patients under 2 years old. Therefore, the investigators might include more than 24 fluid expansions if some are administrated to patients older than 2 years old. Without this correction, our study might be underpowered if age is found to be a bias in fluid responsiveness.
Who may be able to join
- Age lower than 15 years old
- Prescription of a 10 to 20ml/kg crystalloid fluid expansion by the physician in charge
- Acute circulatory failure defined by the association of an A criteria (increase of heart rate more than two standard deviation for the age, decrease of systolic or mean blood pressure more than two standard deviation for ) and a B criteria (lactate more than 2 mmol/L, oliguria less than 1mL/kg/h, a capillary filling time more than 3 seconds, mottling)
- Patient hospitalized in PICU
Who cannot join
- Prematurity (term below 37 gestational week).
- Acute cardiogenic pulmonary edema
- Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
- Non corrected congenital cardiopathy, or inferior to 15 days postoperative.
- Intra-abdominal hypertension or painful abdominal palpation
- Abdominal surgery in the last 15 days
Show all 9Show fewer
- Supine position contraindicated or deleterious
- No investigator available to assess ultrasonographic measures
- Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren - The FRENCH Study
In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).
Read the detailed description
Fluid expansion is the cornerstone of acute circulatory failure treatment in children 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. 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. However, 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. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.
In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in children with acute circulatory failure, hospitalized in pediatric intensive care unit (PICU) for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.
In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion. Patients will be follow-up until PICU discharge.
- Conditions
- Circulatory Failure (Shock)
- Being tested
- Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).
- Keywords
- shock, volume expansion, goal-directed fluid management, echocardiography
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).Procedure or surgery
Fluid expansion will be delayed while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard).
Our index test is the ΔSVi-AC: indexed percentage of stroke volume variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by transthoracic echocardiography.
Patient will undergo 3 echocardiographic assessment: At baseline, During abdominal compression, After the 10 to 20ml/kg crystalloid fluid expansion Abdominal compression : a sphygmomanometer will be inflated to a pressure of less than 10 mmHg and will be applied to the center of the patient's abdomen. Then, a gentle compression on the sphygmomanometer will be performed, calibrated at 22 - 26 mmHg according to the sphygmomanometer. The echocardiographic assessments will take place between 10 and 60 seconds after the start of the compression, which will therefore last less than a minute.
| Study group | Role | What they receive |
|---|---|---|
| study of diagnostic accuracy | Patients included in this study would have received fluid expansion in all cases, as the prescription of 10 to 20ml/kg crystalloid fluid expansion by the physician in charge is the main inclusion criterion. Receives: Procedure: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between Stroke Volume (SV) after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment.
Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment.
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Secondary outcomes (12)
Association between elevated ΔSVi-AC and capillary filling time (sec) -Baseline
Association between elevated ΔSVi-AC and capillary filling time (sec). Normal value: < 3 seconds
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and capillary filling time (sec) -after abdominal compression
Association between elevated ΔSVi-AC and capillary filling time (sec). Normal value: < 3 seconds.
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Heart rate (bpm). -Baseline
Association between elevated ΔSVi-AC and Heart rate (bpm). Normal value: < 2 standard deviation for the age
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Heart rate (bpm). -after abdominal compression
Association between elevated ΔSVi-AC and Heart rate (bpm). Normal value: < 2 standard deviation for the age
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -Baseline
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). Normal value: < 2 standard deviation for the age
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -after abdominal compression
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). Normal value: < 2 standard deviation for the age
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and urine output (ml/kg/h). -Baseline
Association between elevated ΔSVi-AC and Urine output (ml/kg/h). Normal value: > 1ml/kg/h.
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and urine output (ml/kg/h). -after abdominal compression
Association between elevated ΔSVi-AC and Urine output (ml/kg/h). Normal value: > 1ml/kg/h.
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -Baseline
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). Normal value: < 2mmol/L
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -after abdominal compression
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). Normal value: < 2mmol/L
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -Baseline
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). Normal value: >70%
Measured: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -after abdominal compression
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). Normal value: >70%
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start3 Feb 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulatory Failure (Shock)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien GOTCHAC, MD, Principal investigator, Bordeaux hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919719
- Sponsor's protocol ID
- CHUBX 2021/48
- Acronym
- FRENCH
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gotchac J, Navion A, Belaroussi Y, Klifa R, Amedro P, Guichoux J, Brissaud O. Clinical value of calibrated abdominal compression plus transthoracic echocardiography to predict fluid responsiveness in critically ill infants: a diagnostic accuracy study. BMC Pediatr. 2025 May 7;25(1):361. doi: 10.1186/s12887-025-05728-z.
PubMed 40329198
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren - The FRENCH Study
- ClinicalTrials.gov ID
- NCT05919719
- Acronym / sponsor ID
- FRENCH / CHUBX 2021/48
- Conditions
- Circulatory Failure (Shock)
- Keywords
- shock, volume expansion, goal-directed fluid management, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 Jun 2023 (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, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).
Detailed description
Fluid expansion is the cornerstone of acute circulatory failure treatment in children 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. 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. However, 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. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.
In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in children with acute circulatory failure, hospitalized in pediatric intensive care unit (PICU) for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.
In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion. Patients will be follow-up until PICU discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study of diagnostic accuracy | – | Procedure: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).Patients included in this study would have received fluid expansion in all cases, as the prescription of 10 to 20ml/kg crystalloid fluid expansion by the physician in charge is the main inclusion criterion. |
Who may qualify
- Ages
- 1 minute to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- At least 24 fluid expansion are needed, in 10 to 24 patients (maximum of 3 fluid expansion per patient). The "number needed to treat" was calculated with Obuchowski method, with an aphla risk of 0.05, a statistical power of 80%, a ratio "responder/nonresponder" of 1:1, and a predicted area under the receiver operating characteristic curve of 0.78 (based on previous studies). In order to be clinically relevant, since a large majority of patients admitted to our PICU are under 2 years of age, the investigators plan to include 24 fluid expansions administrated to patients under 2 years old. Therefore, the investigators might include more than 24 fluid expansions if some are administrated to patients older than 2 years old. Without this correction, our study might be underpowered if age is found to be a bias in fluid responsiveness.
Key inclusion criteria (4 listed)
- Age lower than 15 years old
- Prescription of a 10 to 20ml/kg crystalloid fluid expansion by the physician in charge
- Acute circulatory failure defined by the association of an A criteria (increase of heart rate more than two standard deviation for the age, decrease of systolic or mean blood pressure more than two standard deviation for ) and a B criteria (lactate more than 2 mmol/L, oliguria less than 1mL/kg/h, a capillary filling time more than 3 seconds, mottling)
- Patient hospitalized in PICU
Key exclusion criteria (9 listed)
- Prematurity (term below 37 gestational week).
- Acute cardiogenic pulmonary edema
- Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
- Non corrected congenital cardiopathy, or inferior to 15 days postoperative.
- Intra-abdominal hypertension or painful abdominal palpation
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 |
|---|---|---|
| Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).Fluid expansion will be delayed while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard). Our index test is the ΔSVi-AC: indexed percentage of stroke volume variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by transthoracic echocardiography. Patient will undergo 3 echocardiographic assessment: At baseline, During abdominal compression, After the 10 to 20ml/kg crystalloid fluid expansion Abdominal compression : a sphygmomanometer will be inflated to a pressure of less than 10 mmHg and will be applied to the center of the patient's abdomen. Then, a gentle compression on the sphygmomanometer will be performed, calibrated at 22 - 26 mmHg according to the sphygmomanometer. The echocardiographic assessments will take place between 10 and 60 seconds after the start of the compression, which will therefore last less than a minute. | Procedure or surgery | study of diagnostic accuracy |
Primary outcome
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between Stroke Volume (SV) after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment. Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment.
12 secondary outcomes
Association between elevated ΔSVi-AC and capillary filling time (sec) -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and capillary filling time (sec) -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Heart rate (bpm). -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Heart rate (bpm). -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and urine output (ml/kg/h). -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and urine output (ml/kg/h). -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -Baseline
Time frame: at baseline (before fluid expansion)
Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -after abdominal compression
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
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 26 Jun 2023.
- Derived from this study: PubMed 40329198Gotchac J, Navion A, Belaroussi Y, Klifa R, Amedro P, Guichoux J, Brissaud O. Clinical value of calibrated abdominal compression plus transthoracic echocardiography to predict fluid responsiveness in critically ill infants: a diagnostic accuracy study. BMC Pediatr. 2025 May 7;25(1):361. doi: 10.1186/s12887-025-05728-z.
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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.
Julien GOTCHAC, MD principal investigator
Bordeaux hospital University
1 site 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 (Shock), run by University Hospital, Bordeaux at 1 site 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 4 inclusion and 9 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness (time frame: after abdominal compression, 30 minutes to 4 hours after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919719, which also lists 1 linked publication.
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 26 Jun 2023.