Clinical trial NCT06710275: Pronostic Value of Gap CO2 During Cardiac Pulmonary Bypass in Cardiac Surgery: a Multicenter Retrospective Study
Official title: Étude rétrospective de la Valeur Pronostique du pCO2 Gap Durant la Circulation Extracorporelle en Chirurgie Cardiaque
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery Associated Kidney Injury
Keywords: Cardiac surgery
AKI
Cardiopulmonary bypass
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18, which underwent cardiac surgery with cardiopulmonary bypass

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.

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.

Non-inclusion criteria :

1. Heart transplant patients
2. Patients who have received long-term cardiac assistance
3. Minor patients

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: within the 7 days after surgery
Secondary outcomes:
measure: Mortality, occurrence of other complications
timeFrame: within the 28 days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Anesthésie Réanimation, Hôpital de la Pitié-Salpêtrière
city: Rennes
country: France
facility: Service d'Anesthésie-Réanimation, Hôpital Pontchaillou, Rennes
Study officials:
References: