Metabolic Fluid Responsiveness in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-15
SponsorUniversity Hospital, Bordeaux
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
at baselineSecondary outcomes
1
AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )
Baseline arterial lactate (mmol.L-1), from an arterial blood gas analysis
Time frame
at baseline2
AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )
Baseline central venous oxygen saturation (%), from a central venous blood gas analysis
Time frame
at baseline3
AUROC (%) of the following index test to diagnose metabolic fluid responsiveness (same definition as above )
Baseline Pv-aCO2 (mmHg), from an arterial and central venous blood gas analysis
Time frame
at baseline4
Subgroup analysis of the primary outcome
age, type of fluid expansion, circulatory physiology
Time frame
at baselineSponsors and contacts
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Source ClinicalTrials.gov