Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children

NCT07522580 | Recruiting

• 2 other identifiers: CHUBX 2025/0192025-A01029-40
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Shock State; Fluid Therapy; Circulatory Failure

Keywords

Circulatory failure; Critical Care; Echocardiography; Electrical Cardiometry; Fluid therapy; Fluid responsiveness; Goal-directed fluid management; pediatrics; volume expansion

Outcome Measures

Primary Outcomes (1)

• 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

  between baseline and 1 hour

Secondary Outcomes (27)

• AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )

  between baseline and 1 hour

• AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )

  between baseline and 1 hour

• AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )

  between baseline and 1 hour

• AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )

  between baseline and 1 hour

• AUROC (%) of the following index test to diagnose fluid responsiveness (same definition as above )

  between baseline and 1 hour

Study Arms (1)

Patient in paediatric intensive care unit

Diagnostic Test: validation a test of fluid-responsiveness in critically ill children

Interventions

validation a test of fluid-responsiveness in critically ill children DIAGNOSTIC_TEST

This test is based on an assessment of the hemodynamic effects of a standardized abdominal compression, using electrical cardiometry.

Patient in paediatric intensive care unit

Eligibility Criteria

• Age: 0 Days - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

patient hospitalised in intensive care or in a continuous monitoring unit

You may qualify if:

• Age less than or equal to 8 years old
• Hospitalization in a pediatric intensive care unit
• Prescription by the attending physician of a fluid expansion of 10ml/kg
• Use of a non-invasive cardiac output monitoring device (electrical cardiometry) as part of routine care

You may not qualify if:

• Patient less than 37 weeks' corrected gestational age
• Hemodynamic instability making the delay necessary for any test dangerous
• Supine position contraindicated or deleterious
• Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
• Opposition to participate expressed by the patient or by a parent or legal guardian
• Intra-abdominal hypertension, painful abdominal palpation or abdominal surgery in the last 15 days

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

Hôpital Marie Lannelongue

Le Plessis-Robinson, France, 92350, France

NOT YET RECRUITING

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, France, 34295, France

NOT YET RECRUITING

Hôpital mère-enfant - CHU de Nantes

Nantes, France, 44093, France

NOT YET RECRUITING

Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux

Pessac, France, 33600, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien GOTCHAC, MD

  Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux

  STUDY DIRECTOR

Central Study Contacts

Julien GOTCHAC, MD

CONTACT

+33 5 24 54 92 19; julien.gotchac@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: April 13, 2026
• Study Start: July 22, 2025
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): August 19, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

FR (4)