Simplified electrical cardiometry test to predict which critically ill children will respond to fluids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational diagnostic accuracy study will test whether changes in stroke volume measured by noninvasive electrical cardiometry during a standardized abdominal compression predict which children will increase stroke volume after a 10 ml/kg fluid bolus. Children ≤8 years in participating pediatric intensive care units who are prescribed a fluid expansion and already monitored with electrical cardiometry will undergo a brief, standardized abdominal compression while continuous cardiometry records stroke volume variation. The cardiometry-derived response will be compared to the reference standard—echocardiographic stroke volume measured before and after the fluid bolus, with fluid responsiveness defined as a ≥15% increase. Diagnostic accuracy metrics (sensitivity, specificity, and predictive values) will be calculated to determine whether the cardiometry maneuver can speed bedside decisions and reduce reliance on operator-dependent echocardiography.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux
  Pessac, France, France Recruiting
• Hôpital Marie Lannelongue
  Le Plessis-Robinson, France, France Not yet recruiting
• Hôpital Arnaud de Villeneuve - CHU de Montpellier
  Montpellier, France, France Not yet recruiting
• Hôpital mère-enfant - CHU de Nantes
  Nantes, France, France Not yet recruiting

Study contacts

• Study coordinator: Julien GOTCHAC, MD
• Email: julien.gotchac@chu-bordeaux.fr
• Phone: +33 5 24 54 92 19

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.