Predicting which children benefit from fluid treatment after heart surgery

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

Researchers will enroll children up to 15 years old in pediatric intensive care after cardiac surgery who have functioning arterial and central venous lines and for whom a 10 ml/kg fluid bolus is prescribed. Baseline arterial and central venous blood gases will be collected to calculate the Pv–aCO2/CavO2 ratio, and oxygen consumption (VO2) will be measured before and after the fluid expansion. The main analysis will determine how accurately the baseline Pv–aCO2/CavO2 ratio predicts a significant increase in VO2 (metabolic fluid responsiveness). The study is observational and uses routine clinical care and timed blood sampling without altering standard treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age less than or equal to 15 years old
* Hospitalization in a pediatric intensive care unit after cardiac surgery
* Prescription by the attending physician of a fluid expansion of 10ml/kg
* Prescription of arterial and venous blood gas before and after the volume expansion to help manage acute circulatory failure
* Patient implanted with a functioning arterial line
* Patient implanted with a functioning central venous line in the superior vena cava territory

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

Where it's running

• Hôpital Louis Pradel - Hospices Civils de Lyon
  Bron, France, France Recruiting
• Hôpital Jeanne de Flandre - CHU de Lille
  Lille, France, France Recruiting
• Hôpital mère-enfant - CHU de Nantes
  Nantes, France, France Recruiting
• Hôpital Necker-Enfants Malades - Assistance Publique - Hôpitaux de Paris
  Paris, France, France Recruiting
• Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux
  Pessac, France, France Recruiting
• Hôpital Felix Guyon - CHU de la Réunion
  Saint-Denis, La Réunion, France Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effects of fluid infusion rates on blood circulation during surgery

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• Determining the best IV fluid amount for children after trauma

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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.