Actively Recruiting

Age: 0Days - 15Years
All Genders
ID07255469

Parameters Associated With Metabolic Response to Volume Expansion in Children Post-operative of Cardiac Surgery

Led by University Hospital, Bordeaux · Updated on 2025-12-01

110

Participants Needed

8

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying metabolic fluid responsiveness in children who experience acute circulatory failure after cardiac surgery. The goal is to find markers that help doctors decide which children might benefit from fluid expansion, avoiding unnecessary and potentially harmful fluid overload. This study focuses on evaluating the accuracy of a blood marker ratio called Pv-aCO2 to CavO2 to diagnose metabolic fluid responsiveness, defined as a significant increase in oxygen consumption after fluid expansion. This non-interventional, multicenter study in pediatric intensive care units involves children up to 15 years old who have had cardiac surgery and require fluid expansion as prescribed by their physician. The study measures oxygen consumption before and within one hour after fluid expansion using echocardiography combined with blood gas analyses from existing arterial and central venous lines. No additional invasive tests or blood draws are performed, and data such as hemodynamic and clinical information are collected from routine monitoring and medical records. Participants will undergo assessments at baseline and shortly after fluid expansion, including blood gas tests and echocardiography to measure cardiac output and oxygen content differences. The main measure is the diagnostic accuracy of the Pv-aCO2/CavO2 ratio in predicting metabolic fluid responsiveness. Secondary analyses include other blood markers, tissue oxygen saturation changes, and correlations with clinical profiles. Safety monitoring is inherent in standard care, and the study is expected to enroll 110 children with a follow-up period as specified by clinical practice.

CONDITIONS

Brief Title

Metabolic Fluid Responsiveness in Children

Who Can Participate

Age: 0Days - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age less than or equal to 15 years old
  • Hospitalized in a pediatric intensive care unit after cardiac surgery
  • Fluid expansion of 10 ml/kg prescribed by the attending physician
  • Arterial and venous blood gas tests prescribed before and after fluid expansion
  • Patient has a functioning arterial line
  • Patient has a functioning central venous line in the superior vena cava territory
Not Eligible

You will not qualify if you...

  • Patient less than 37 weeks' corrected gestational age
  • Hemodynamic instability making any delay for tests dangerous
  • Supine position is contraindicated or harmful
  • Echocardiographic acoustic window impaired or patient too restless for ultrasound
  • Patient or legal guardian opposes participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Less than 1 day

Participants undergo measurements including echocardiographic assessment and arterial and venous blood gas tests before and after fluid expansion to evaluate metabolic fluid responsiveness.

1 baseline visit and 1 follow-up visit within 1 hour

Long-term Monitoring

Duration - Up to 28 days

Additional clinical data and outcomes related to metabolic fluid responsiveness are collected and analyzed.

Assessments at baseline and day 28

Trial Site Locations

Total: 8 locations

1

Hôpital Louis Pradel - Hospices Civils de Lyon

Bron, France, France, 69500

Actively Recruiting

2

Hôpital Jeanne de Flandre - CHU de Lille

Lille, France, France, 59000

Actively Recruiting

3

Hôpital de la Timone - Assistance Publique - Hôpitaux de Marseille

Marseille, France, France, 13385

Not Yet Recruiting

4

Hôpital mère-enfant - CHU de Nantes

Nantes, France, France, 44093

Actively Recruiting

5

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

Paris, France, France, 75015

Actively Recruiting

6

Hôpital Cardiologique Haut Lévêque - CHU de Bordeaux

Pessac, France, France, 33604

Actively Recruiting

7

Hôpital des enfants - CHU de Toulouse

Toulouse, France, France, 31300

Not Yet Recruiting

8

Hôpital Felix Guyon - CHU de la Réunion

Saint-Denis, La Réunion, France, 97400

Actively Recruiting

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Research Team

J

Julin GOTCHAC, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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