An observational study in Circulatory Failure, Shock State and Fluid Therapy, sponsored by University Hospital, Bordeaux. Recruiting at 4 sites in France. Open to participants aged 0 Days to 8 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University Hospital, Bordeaux · Observational
In this study of diagnostic accuracy, the investigators aim to validate a faster, simpler, and noninvasive test of fluid-responsiveness in critically ill children. This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry. This would help physicians to identify more easily which patient 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 electrical cardiometry-based stroke volume (SV) variation induced by a standardized abdominal compression to predict fluid responsiveness (define as a 15% increase in echocardiographically measured SV after volume expansion) will be measured.
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, respiratory variability of peak aortic velocity is the most studied test and has an excellent diagnostic accuracy but is only validated in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, the abdominal compression maneuver has been investigated. This classical clinical maneuver induces a transient and reversible preload increase by increasing the venous return via the mobilization of the hepato-splanchnic venous reservoir. The echocardiographic evaluation of this maneuver can accurately predict fluid responsiveness. However, this echocardiographic assessment is a pitfall, as it is an operator-dependent, discontinuous and time-consuming examination. Therefore, electrical cardiometry could be interesting. This continuous and non-invasive cardiac output monitor could be an interesting alternative to evaluate the hemodynamic effects of the abdominal compression maneuver in order to predict fluid responsiveness.
Therefore, the investigators will evaluate the diagnostic accuracy of an abdominal compression maneuver for the diagnosis of fluid responsiveness in critically ill children, for whom the physician in charge prescribed a 10ml/kg volume expansion for circulatory failure. The index test will be the SV variation induced by an abdominal compression maneuver, with SV being measured with electrical cardiometry. Fluid responsiveness will be defined as a > 15% increase in echocardiographically-measured SV between baseline and within one hour after fluid expansion (gold standard test).
In this non-interventional, prospective, multi-center study of diagnostic accuracy, children requiring a 10ml/kg volume expansion will be included. After a prescription of 10 ml/kg volume expansion by the physician in charge, screening for inclusion and exclusion criteria will be performed by an investigator physician. If the patient is included, volume expansion will be delayed for a few minutes (\<3 min) while an echocardiography and the index test are performed, but no supplemental blood test or invasive parameters will be collected. Another echocardiographic evaluation will be conducted within one hour after volume expansion, to assess response to fluid expansion (gold-standard test). Patients will be follow-up until PICU discharge (28 days maximum).
The index test is the ΔSV-ACICON: percentage of SV variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by electrical cardiometry, a noninvasive cardiac output monitoring.
The abdominal compression maneuver, a common clinical test in critically ill children, will be standardized as follow: a sphygmomanometer will be inflated with 80ml of air and will be applied to the center of the patient's abdomen. Then, the operator's hand will be placed on the sphygmomanometer (which is thus interposed between the patient's abdomen and the operator's hand) and a gentle manual anteroposterior compression will be performed, calibrated at 30 cmH2O according to the sphygmomanometer. Parameters of interest will be collected 30 seconds after the start of the compression.
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:
Statistical analysis: Comparisons between fluid "responders" and "non-responders" will be performed with Student's t-test or Mann-Whitney test for continuous variables; or with the Chi-2 test or Fisher's exact test for categorical variables. Spearman correlation coefficient will be used to test linear correlations.
Fluid responsiveness represents the gold standard test. Patients will be classified as fluid responders in case of at least 15% increase in SV after fluid expansion, compared to baseline.
Diagnostic accuracy of the index tests will be explored. As multiple cut-offs of theses index tests can be defined, the investigators will report a receiver operating characteristic (ROC) curve which graphically represents the combination of sensitivity and specificity for each possible test positivity threshold. The area under the ROC curve and its 95% confidence interval informs in a single numerical value about the overall diagnostic accuracy of the index test. The ROC curves of all index tests will be compared using a DeLong test.
A p value less than 0.05 will be considered statistically significant
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 42 is below the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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patient hospitalised in intensive care or in a continuous monitoring unit
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Diagnostic Test: validation a test of fluid-responsiveness in critically ill children
This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry.
Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness
Description: 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 ΔSV-ACICON = difference between stroke volume measured by electrical cardiometry (ml) during a calibrated abdominal compression (30mmHg for 30 seconds) and stroke volume measured by electrical cardiometry at baseline. * 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 parasternal long axis view) and left ventricular outflow tract velocity-time integral
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Respiratory variability of peak aortic velocity at baseline (%)
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Respiratory variability of inferior vena cava diameter at baseline (%)
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Stroke volume respiratory variations at baseline (%), measured with electrical cardiometry
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Abdominal compression induced variations in arterial pressure (%)
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Abdominal compression induced variations in perfusion index (%)
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Abdominal compression induced variations in end-tidal carbon dioxide (%)
Time frame: between baseline and 1 hour
AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )
Abdominal compression induced variations in arterial pulse pressure variability index (%)
Time frame: between baseline and 1 hour
Diagnostic accuracy (AUROC, %) of all tests above to diagnose a significant increase (>15%) in mean arterial pressure after volume expansion
Time frame: between baseline and 1 hour
Subgroup analysis of the primary outcome: age, type of fluid expansion, ventilation status, circulatory physiology
Time frame: between baseline and 1 hour
Correlation between fluid responsiveness and the following.
Age category (0 - 2 years / 2 - 8 years)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Reason for intensive care admission (cardiac surgery, univentricular circulation / cardiac surgery, biventricular circulation / other)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Sex
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Weight at baseline (kg)
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Number of fluid expansion during the last 24 hours before inclusion
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Baseline Heart rate (bpm)
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Baseline arterial pressure (mmHg)
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Baseline urine output (ml/kg/h)
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Baseline capillary refill time (s)
Time frame: At baseline; After fluid expansion (see Primary Outcome Measure for Time Frame precise definition); Day 28.
Correlation between fluid responsiveness and the following.
Baseline mottling (yes/no)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Baseline PELODS2 score (n)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Type of volume expansion (albumin or crystalloid)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Length of mechanical ventilation (days), evaluated 28 days after inclusion
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Intensive care unit length of stay (days), evaluated 28 days after inclusion
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
Mortality at 28 days after inclusion (yes/no)
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
% of increase in mean perfusion pressure (i.e. difference between mean arterial pressure and central venous pressure, mmHg) between baseline and after volume expansion
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
% of increase in central venous pressure (mmHg) between baseline and after volume expansion
Time frame: At baseline; 1 hour ; Day 28.
Correlation between fluid responsiveness and the following.
% of increase in stroke volume (ml) measured by electrical cardiometry between baseline and after volume expansion
Time frame: At baseline; 1 hour ; Day 28.
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