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NCT Number: NCT07770386

Performance of CO2-derived Parameters in Predicting Low Cardiac Output Syndrome

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.

CO2-derived parameters are increasingly used to identify low cardiac output status by the PCO2 gap, or anaerobic metabolism by the 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.

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Key information

Conditions

Low Cardiac Output Syndrome Bypass Children Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, France

Location status: Recruiting

Location contact

Celine CLAIRET-LESPINASSE

CONTACT

[email protected]

+33320444145

Morgan RECHER, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ROC curve of PCO2 gap

    Time frame: 2 hours

Secondary outcomes

  1. ROC curve of Pv-aCO2/Ca-vO2

    Time frame: 2 hours

  2. Pv-aCO2/Ca-vO2 and post-operatory complications

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Celine CLAIRET-LESPINASSE

CONTACT

[email protected]

+33 3204441145

DRS. Promotion

CONTACT

[email protected]

+33 3204441145

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: GAP-CO2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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