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

NCT07770386 | Recruiting

• 1 other identifier: 2023_0044
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Cardiac Output Syndrome Bypass Children

Keywords

Low cardiac output syndrome; children; bypass; congenital cardiopathy

Outcome Measures

Primary Outcomes (1)

• Receiver Operating Characteristic (ROC) curve of PCO2 gap

  2 hours

Secondary Outcomes (2)

• ROC curve of Pv-aCO2/Ca-vO2

  2 hours

• Pv-aCO2/Ca-vO2 and post-operatory complications

  48 hours

Eligibility Criteria

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

Study Population

Children after cardiac surgery with cardiopulmonary bypass (CPB)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Celine CLAIRET-LESPINASSE

CONTACT

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

DRS. Promotion

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: June 27, 2026
• Primary Completion (Estimated): June 27, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)