Low Cardiac Output Syndrome Bypass ChildrenGAP-CO2NCT07770386
Performance of Carbon Dioxide (CO2)-Derived Parameters in Predicting Low Cardiac Output Syndrome
An observational study of Low Cardiac Output Syndrome Bypass Children, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Low Cardiac Output Syndrome Bypass Children
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children after cardiac surgery with cardiopulmonary bypass (CPB)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Lille
Lille
Celine CLAIRET-LESPINASSE, +33320444145, celine.clairet@chu-lille.fr
Morgan RECHER, Doctor
About this study
Official title: Performance of CO2-derived Parameters in Predicting Low Cardiac Output Syndrome in Children After Cardiac Surgery With Cardiopulmonary Bypass
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.
- Keywords
- Low cardiac output syndrome, children, bypass, congenital cardiopathy
- Medical subject headings
- Cardiac Output, Low
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver Operating Characteristic (ROC) curve of PCO2 gap
Measured: 2 hours
Secondary outcomes (2)
ROC curve of Pv-aCO2/Ca-vO2
Measured: 2 hours
Pv-aCO2/Ca-vO2 and post-operatory complications
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start27 Jun 2026
- Primary completion27 Jun 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Cardiac Output Syndrome Bypass ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770386
- Sponsor's protocol ID
- 2023_0044
- Acronym
- GAP-CO2
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of CO2-derived Parameters in Predicting Low Cardiac Output Syndrome in Children After Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07770386
- Acronym / sponsor ID
- GAP-CO2 / 2023_0044
- Keywords
- Low cardiac output syndrome, children, bypass, congenital cardiopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 Jun 2026 (actual)
- Primary completion
- 27 Jun 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children after cardiac surgery with cardiopulmonary bypass (CPB)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Receiver Operating Characteristic (ROC) curve of PCO2 gap
Time frame: 2 hours
2 secondary outcomes
ROC curve of Pv-aCO2/Ca-vO2
Time frame: 2 hours
Pv-aCO2/Ca-vO2 and post-operatory complications
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Cardiac Output Syndrome Bypass Children, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celine CLAIRET-LESPINASSE (+33 3204441145, celine.clairet@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receiver Operating Characteristic (ROC) curve of PCO2 gap (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.