ClinicalTrials.gg
RecruitingNCT07770386GAP-CO2Updated Sep 9, 2026

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

An observational study in Low Cardiac Output Syndrome Bypass Children, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
306
Ages
Up to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Cardiac Output Syndrome Bypass Children

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Keywords

  • Low cardiac output syndrome
  • children
  • bypass
  • congenital cardiopathy
03

In context

Cardiac Output, Low

99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's planned enrollment of 306 is above the median of 66 across 48 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children after cardiac surgery with cardiopulmonary bypass (CPB)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
306 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Receiver Operating Characteristic (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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.

Of 22 observational studies under Cardiac Output, Low, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 18, 2026
StartActual
Jun 27, 2026
Primary completionEst.
Jun 27, 2029
CompletionEst.
Jul 2029
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07770386
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Jun 27, 2026
Primary completion
Jun 27, 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Celine CLAIRET-LESPINASSE
Contact
celine.clairet@chu-lille.fr
+33 3204441145
DRS. Promotion
Contact
drs.promotion@chu-lille.fr
+33 3204441145

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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