NCT07522580 Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
| NCT ID | NCT07522580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Circulatory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2027-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 42 participants in total. It began in 2025-07-22 with a primary completion date of 2027-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Julien GOTCHAC, MD
STUDY DIRECTOR
Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux
Frequently Asked Questions
Who can join the NCT07522580 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 8 Years, studying Circulatory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07522580 currently recruiting?
Yes, NCT07522580 is actively recruiting participants. Contact the research team at julien.gotchac@chu-bordeaux.fr for enrollment information.
Where is the NCT07522580 trial being conducted?
This trial is being conducted at Le Plessis-Robinson, France, Montpellier, France, Nantes, France, Pessac, France.
Who is sponsoring the NCT07522580 clinical trial?
NCT07522580 is sponsored by University Hospital, Bordeaux. The principal investigator is Julien GOTCHAC, MD at Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux. The trial plans to enroll 42 participants.