Predicting which children benefit from fluid treatment after heart surgery
Parameters Associated With Metabolic Response to Volume Expansion in Children Post-operative of Cardiac Surgery
This study will test whether a simple blood gas ratio (Pv–aCO2/CavO2) can tell which children in intensive care after cardiac surgery will increase their oxygen use after a 10 ml/kg fluid bolus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 0 Days to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 8 sites (Bron, France and 7 other locations) |
| Trial ID | NCT07255469 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children ≤15 years old in a participating pediatric ICU after cardiac surgery who have arterial and central venous lines and are prescribed a 10 ml/kg fluid expansion.
Not a fit: Preterm infants under 37 weeks corrected gestational age, patients too unstable to delay care or without required vascular access, and those with contraindications to supine positioning or echocardiography are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, clinicians could target fluid therapy to children who will truly improve oxygen delivery and avoid harmful fluid overload in others.
How similar studies have performed: Similar blood-gas–based markers have shown promise in adult studies, but the Pv–aCO2/CavO2 ratio has not been validated for metabolic fluid responsiveness in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bron, France and 7 other locations
- Hôpital Louis Pradel - Hospices Civils de Lyon — Bron, France, France (Recruiting)
- Hôpital Jeanne de Flandre - CHU de Lille — Lille, France, France (Recruiting)
- Hôpital de la Timone - Assistance Publique - Hôpitaux de Marseille — Marseille, France, France (Not_yet_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 des enfants - CHU de Toulouse — Toulouse, France, France (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.