Metabolic Fluid Responsiveness in Children

NCT07255469 | Recruiting

• 2 other identifiers: CHUBX 2024/872024-A02561-46
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 8

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.

Conditions

Circulatory Failure / Shock State; Fluid Therapy

Keywords

Circulatory failure; Critical Care; Echocardiography; Fluid therapy; Fluid responsiveness; Goal-directed fluid management; oxygen consumption; pediatrics; volume expansion

Outcome Measures

Primary Outcomes (1)

• Area under the ROC curve (AUROC, %) of baseline Pv-aCO2/DAVO2 ratio to diagnose metabolic fluid

  The primary outcome measure of a diagnostic accuracy study is the discriminative ability of an index test (expressed as an area under the ROC curve) to diagnose a condition (defined by a positive gold-standard reference test). In this study: * The index test is the baseline Pv-aCO2/DAVO2 ratio, i.e. the ratio between the veno-arterial carbon dioxide partial pressure gradient (mmHg) and the difference between arterial and venous oxygen content (ml.dl-1). Oxygen content and carbon dioxide partial pressure are measured by arterial and central venous blood gas analysis. * The condition is "metabolic fluid responsiveness" * The gold-standard reference test to diagnose metabolic fluid responsiveness is a VO2 increase of at least 15% between baseline and after volume expansion (i.e. ((VO2 after volume expansion - VO2 at baseline) / VO2 at baseline) \> 15%). VO2 (ml/min/m2) will be measured as follow: VO2=(10.CO.DAVO2)/(Body Surface Area), where CO (ml.min-1) is the cardiac output, measured b

  at baseline

Secondary Outcomes (6)

• AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )

  at baseline

• AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )

  at baseline

• AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )

  at baseline

• Subgroup analysis of the primary outcome

  at baseline

• Correlation between metabolic fluid responsiveness and the following

  at baseline

Eligibility Criteria

• Age: 0 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in an intensive care unit after cardiac surgery with a prescription of a 10ml/kg fluid expansion by the physician in charge

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (8)

Hôpital Louis Pradel - Hospices Civils de Lyon

Bron, France, 69500, France

RECRUITING

Hôpital Jeanne de Flandre - CHU de Lille

Lille, France, 59000, France

RECRUITING

Hôpital de la Timone - Assistance Publique - Hôpitaux de Marseille

Marseille, France, 13385, France

NOT YET RECRUITING

Hôpital mère-enfant - CHU de Nantes

Nantes, France, 44093, France

RECRUITING

Hôpital Necker-Enfants Malades - Assistance Publique - Hôpitaux de Paris

Paris, France, 75015, France

RECRUITING

Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux

Pessac, France, 33604, France

RECRUITING

Hôpital des enfants - CHU de Toulouse

Toulouse, France, 31300, France

NOT YET RECRUITING

Hôpital Felix Guyon - CHU de la Réunion

Saint-Denis, La Réunion, 97400, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien GOTCHAC, MD

  CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

  STUDY DIRECTOR

Central Study Contacts

Julin GOTCHAC, MD

CONTACT

+33 5 24 54 92 19; julien.gotchac@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: December 1, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): April 18, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (8)