Cardiac Surgery Associated Kidney InjuryCO2-CARDNCT06710275
Pronostic Value of Gap CO2 During Cardiac Pulmonary Bypass in Cardiac Surgery: a Multicenter Retrospective Study
An observational study of Cardiac Surgery Associated Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Associated Kidney Injury
- How many people
- 318 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Feb 2025to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18, which underwent cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Informed patients who did not object to the use of their data in the study.
- Patients undergoing cardiac surgery with extracorporeal circulation.
- Patients for whom a pCO2 gap measurement is available during ECG.
- Non-inclusion criteria :
- Heart transplant patients
- Patients who have received long-term cardiac assistance
- Minor patients
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Anesthésie Réanimation, Hôpital de la Pitié-Salpêtrière
Paris, 75571
Service d'Anesthésie-Réanimation, Hôpital Pontchaillou, Rennes
Rennes
About this study
Official title: Étude rétrospective de la Valeur Pronostique du pCO2 Gap Durant la Circulation Extracorporelle en Chirurgie Cardiaque
Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In this study, the investigators aim to explore the use of gap CO2 during cardiac surgery and its relation with CSA-AKI. In order to explore this association, the invetigators built a retrospective, multicentric study. All patient who underwent cardiac surgery with cardiopulmonary bypass in two French ICU between 03/2019 and 04/2023 and for which information about gap CO2 during CPB is available will be included. After inclusion, patient will be divided in two groups according to the presence or absence of an elevated gap CO2. Occurence of CSA-AKI and other outcomes will be compared between groups, using multivariate analysis.
Read the detailed description
Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In order to explore this association, investigators build a retrospective study including all patients who underwent cardiac surgery requiring CPB in two French hospitals and for which data about gap CO2 during CPB is available. Patients will be divided into two groups according to the presence or absence of an elevated gap CO2 during CPB, defined as > 6 mmHg. The primary outcome is the occurrence of CSA-AKI, defined by KDIGO recommendations, according gap CO2. Secondary outcomes include others post-operative complications as defined by international guidelines. Performance of gap CO2 to predict CSA-AKI will be evaluated by calculating the Area Under the Curve (AUC) of the associated ROC curve. We'll also assess the correlation between gap CO2 and other perfusion parameters (lactate, svO2) and with mean DO2 during CPB.
- Conditions
- Cardiac Surgery Associated Kidney Injury
- Keywords
- Cardiac surgery, AKI, Cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elevated gap CO2 group and low gap CO2 group | Gap CO2 is calculated as PvCO2-PaCO2, using arterial and venous blood gases taken during CPB. Patients will be included in the elevated gap CO2 group when gap CO2 during CPB is > 6 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
proportion of patient with acute kidney injury of Acute Kidney Injury as defined in the KDIGO guidelines within the first 7 days after the cardiac surgery
Measured: within the 7 days after surgery
Secondary outcomes (1)
Mortality, occurrence of other complications
proportion of patient with others post-operative complications as defined by international post-operative guidelines: atrial fibrillation, ARDS , VA-ECMO implantation, cardiac arrest, length of stay in ICU and hospital and the mortality rate within the first 28 days
Measured: within the 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start27 Feb 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710275
- Sponsor's protocol ID
- APHP241392
- Acronym
- CO2-CARD
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude rétrospective de la Valeur Pronostique du pCO2 Gap Durant la Circulation Extracorporelle en Chirurgie Cardiaque
- ClinicalTrials.gov ID
- NCT06710275
- Acronym / sponsor ID
- CO2-CARD / APHP241392
- Conditions
- Cardiac Surgery Associated Kidney Injury
- Keywords
- Cardiac surgery, AKI, Cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 29 Nov 2024 (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.
Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In this study, the investigators aim to explore the use of gap CO2 during cardiac surgery and its relation with CSA-AKI. In order to explore this association, the invetigators built a retrospective, multicentric study. All patient who underwent cardiac surgery with cardiopulmonary bypass in two French ICU between 03/2019 and 04/2023 and for which information about gap CO2 during CPB is available will be included. After inclusion, patient will be divided in two groups according to the presence or absence of an elevated gap CO2. Occurence of CSA-AKI and other outcomes will be compared between groups, using multivariate analysis.
Detailed description
Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In order to explore this association, investigators build a retrospective study including all patients who underwent cardiac surgery requiring CPB in two French hospitals and for which data about gap CO2 during CPB is available. Patients will be divided into two groups according to the presence or absence of an elevated gap CO2 during CPB, defined as > 6 mmHg. The primary outcome is the occurrence of CSA-AKI, defined by KDIGO recommendations, according gap CO2. Secondary outcomes include others post-operative complications as defined by international guidelines. Performance of gap CO2 to predict CSA-AKI will be evaluated by calculating the Area Under the Curve (AUC) of the associated ROC curve. We'll also assess the correlation between gap CO2 and other perfusion parameters (lactate, svO2) and with mean DO2 during CPB.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elevated gap CO2 group and low gap CO2 group | – | –Gap CO2 is calculated as PvCO2-PaCO2, using arterial and venous blood gases taken during CPB. Patients will be included in the elevated gap CO2 group when gap CO2 during CPB is > 6 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18, which underwent cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (7 listed)
- Informed patients who did not object to the use of their data in the study.
- Patients undergoing cardiac surgery with extracorporeal circulation.
- Patients for whom a pCO2 gap measurement is available during ECG.
- Heart transplant patients
- Patients who have received long-term cardiac assistance
Key exclusion criteria (0 listed)
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
Acute Kidney Injury
Time frame: within the 7 days after surgery
proportion of patient with acute kidney injury of Acute Kidney Injury as defined in the KDIGO guidelines within the first 7 days after the cardiac surgery
1 secondary outcome
Mortality, occurrence of other complications
Time frame: within the 28 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Associated Kidney Injury, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: within the 7 days after surgery). 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 24 Apr 2025.