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

Not yet recruiting

• Conditions: Cardiac Surgery Associated Kidney Injury

• Registration Number: NCT06710275
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	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

Secondary Outcome Measures

Name	Time	Method
Mortality, occurrence of other complications	within the 28 days after surgery	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