NCT07255469 Metabolic Fluid Responsiveness in Children
| NCT ID | NCT07255469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Circulatory Failure / Shock State |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-03-21 |
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 110 participants in total. It began in 2025-03-21 with a primary completion date of 2027-03-21.
⚠ 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
The investigators aim to validate markers of metabolic fluid-responsiveness in children with acute circulatory failure following cardiac surgery. This would allow physicians to identify which patient could benefit the most from fluid expansion, thus avoiding useless and potentially dangerous fluid expansions that could lead to fluid overload. To this end, The investigators will evaluate the diagnostic accuracy of the ratio of central venous to arterial carbon dioxide tension (Pv-aCO2) to arteriovenous oxygen content (CavO2), a simple biological marker of anaerobic metabolism, for the diagnosis of metabolic fluid responsiveness defined as a significant increase in oxygen consumption (VO2) after fluid expansion.
Eligibility 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
Contact & Investigator
Julien GOTCHAC, MD
STUDY DIRECTOR
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
Frequently Asked Questions
Who can join the NCT07255469 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 15 Years, studying Circulatory Failure / Shock State. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07255469 currently recruiting?
Yes, NCT07255469 is actively recruiting participants. Contact the research team at julien.gotchac@chu-bordeaux.fr for enrollment information.
Where is the NCT07255469 trial being conducted?
This trial is being conducted at Bron, France, Lille, France, Marseille, France, Nantes, France and 4 additional locations.
Who is sponsoring the NCT07255469 clinical trial?
NCT07255469 is sponsored by University Hospital, Bordeaux. The principal investigator is Julien GOTCHAC, MD at CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque. The trial plans to enroll 110 participants.