Pronostic Value of Gap CO2 During Cardiac Pulmonary Bypass in Cardiac Surgery: a Multicenter Retrospective Study

NCT ID: NCT06710275

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 318 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2025-04-04

Brief 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 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.

Conditions

Cardiac Surgery Associated Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Informed patients who did not object to the use of their data in the study.

2. Patients undergoing cardiac surgery with extracorporeal circulation.

3. Patients for whom a pCO2 gap measurement is available during ECG.

1. Heart transplant patients

2. Patients who have received long-term cardiac assistance

3. Minor patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Anesthésie Réanimation, Hôpital de la Pitié-Salpêtrière

Paris, , France

Service d'Anesthésie-Réanimation, Hôpital Pontchaillou, Rennes

Rennes, , France

Countries

France

Other Identifiers

APHP241392

Identifier Type: -

Identifier Source: org_study_id