Performance of Carbon Dioxide (CO2)-Derived Parameters in Predicting Low Cardiac Output Syndrome

Performance of CO2-derived Parameters in Predicting Low Cardiac Output Syndrome in Children After Cardiac Surgery With Cardiopulmonary Bypass

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07770386

Acronym

GAP-CO2

Enrollment

306

Registered

2026-08-18

Start date

2026-06-27

Completion date

2029-07-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output Syndrome Bypass Children

Keywords

Low cardiac output syndrome, children, bypass, congenital cardiopathy

Brief summary

In congenital cardiac intensive care, low cardiac output syndrome (LCOS) after surgery is defined by a decrease in cardiac output due to cardiac dysfunction. This syndrome is responsible for postoperative mortality and morbidity, as well as prolonged hospitalization. carbon dioxide (CO2)-derived parameters are increasingly used to identify low cardiac output status by the venous-to-arterial carbon dioxide difference (PCO2 gap), or anaerobic metabolism by the venous-to-arterial carbon dioxide difference to arterial-to-venous oxygen content difference (Pv-aCO2/Ca-vO2) ratio, particularly in septic shock in adults, with or without hypoxemia. The thresholds proposed as pathological values were a PCO2 gap ≥ 6 mmHg and a Pv-aCO2/Ca-vO2 ratio ≥ 1.4 mmHg/ml. However, these markers have not been studied in depth in patients who have undergone cardiac surgery. In adults, studies have focused on the predictive value of the PCO2 gap and Pv-aCO2/Ca-vO2 on postoperative complications. In the pediatric population following cardiac surgery, only retrospective studies exist, with conflicting results on the correlation between the PCO2 gap and cardiac output, and the PCO2 gap and duration of mechanical ventilation. This study aims to compare the performance of CO2-derived parameters in predicting LCOS and anaerobic metabolism in children after cardiac surgery with cardiopulmonary bypass.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* Children under the age of 18 * Post-operative cardiac surgery * Surgery with extracorporeal circulation * With a central venous catheter and an arterial catheter * Admitted to the pediatric intensive care unit at Lille University Hospital * Patient covered by the social security system (or equivalent)

Exclusion criteria

* Pre-existing renal insufficiency prior to cardiac surgery * Opposition from the holder of parental authority * Difficulty understanding or communicating, making it impossible to inform the holder of parental authority * Patient under legal protection (guardianship, curatorship, legal safeguard) * Malposition of the central venous catheter * Malposition of the arterial catheter * Biological samples that cannot be interpreted

Design outcomes

Primary

Measure	Time frame
Receiver Operating Characteristic (ROC) curve of PCO2 gap	2 hours

Secondary

Measure	Time frame
ROC curve of Pv-aCO2/Ca-vO2	2 hours
Pv-aCO2/Ca-vO2 and post-operatory complications	48 hours

Countries

France

Contacts

CONTACTCeline CLAIRET-LESPINASSE

celine.clairet@chu-lille.fr+33 3204441145

CONTACTDRS. Promotion

drs.promotion@chu-lille.fr+33 3204441145

Outcome results