Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children (NCT07522580) | Clinical Trial Compass
RecruitingNot Applicable
Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
France42 participantsStarted 2025-07-22
Plain-language 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.
Who can participate
Age range
0 Days – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the ROC curve (AUROC, %) of ΔSV-ACICON to diagnose fluid responsiveness