Skip to main content
OpenTrials
Completed

NCT Number: NCT06710275

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality, occurrence of other complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Étude rétrospective de la Valeur Pronostique du pCO2 Gap Durant la Circulation Extracorporelle en Chirurgie Cardiaque

Acronym: CO2-CARD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.