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NCT07865533

Immune Responses and Pulmonary Complications After Cardiac Surgery With Cardiopulmonary Bypass

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Cardiac surgery under cardiopulmonary bypass (CPB) is associated with a high incidence of postoperative pulmonary complications (PPCs; 10% to 30% incidence). Ranging from atelectasis to acute respiratory syndrome, PPCs are associated with increased hospital length of stay and mortality. Cardiac surgery with CPB induces a complex pathophysiological response characterized by ischemia-reperfusion, activation of the contact system and hypoventilation. The individual immune and inflammatory response may contribute to the development of PPCs. Exploring the association between immuno-inflammatory response and post-operative clinical outcomes might enable a better understanding of the mechanism associated with PPCs and contribute to a more personalized approach to patient care. This prospective observational cohort study will enroll 100 adult patients scheduled for elective cardiac surgery with CPB. The primary objective of this research is to investigate the association between the perioperative immuno-inflammatory profile and the occurrence of PPCs within the first seven days following cardiac surgery under CPB. To identify these profiles, blood and bronchoalveolar lavage samples will be collected at 5 (T0 -T4) and 2 (T0-T1) different times respectively. Multiple biological analyses (RNA single cell, proteomics, flow cytometry, cell culture experiments) will be performed to characterize the immune and inflammatory response to the surgery. PPCs are defined as atelectasis associated with hypoxemia (PaO2/FiO2 \< 200), pneumonia or acute respiratory distress syndrome. The study hypothesis is that patients who develop PPCs have a different immune and inflammatory response to cardiac surgery with CPB.

Official title: A Study of the Association Between Pulmonary and Systemic Immuno-inflammation and Respiratory Complications Following Cardiac Surgery With Cardiopulmonary Bypass.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-11

Completion Date

2028-07

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Cardiac Surgery Under Extra Corporeal Circulation

Interventions

OTHER

Blood sample collection

Blood samples will be collected on Day 0 (the day of the procedure), Day 1, and Day 2, using the arterial catheter placed as part of routine care.

OTHER

Bronchoalveolar lavage fluid collection

Bronchoalveolar lavage (BAL) fluid collection will be performed on Day 0: * 1 BAL under general anesthesia after induction of anesthesia and before the start of the surgical procedure * 1 BAL under general anesthesia after the surgical procedure, upon arrival in the intensive care unit (4 hours after aortic clamping is released)

Inclusion Criteria : * Adult patient * Who has undergone cardiac surgery with cardiopulmonary bypass * Who has undergone elective surgery scheduled at least 48 hours in advance * Who meets at least 1 major criterion or 2 minor criteria : * Major criteria : * EuroSCORE II ≥ 5% * Moderate to severe COPD (FEV1 \< 80% predicted and FEV1/FVC \< 0.70) or PaCO2 \> 45 mmHg * BMI ≥ 35 kg/m² * Confirmed sleep apnea syndrome (apnea-hypopnea index ≥ 15/h) or STOP-Bang score ≥ 5 or documented non-compliance with CPAP * Significant pulmonary hypertension (systolic pulmonary arterial pressure ≥ 50 mmHg or Mean pulmonary arterial pressure ≥ 20 mmHg) * Redux surgery or combined procedure (surgery on multiple valves or valve surgery combined with coronary artery bypass grafting) * Minor criteria : * Age ≥ 70 years * BMI ≥ 30 kg/m² and \< 35 kg/m² * Current smoking (≥ 10 pack-years) * Restrictive respiratory failure (FVC \< 70% or parietal-thoracic pathology) * LVEF \< 40% * Chronic kidney disease (eGFR \< 45 mL/min/1.73 m²) * Frailty score ≥ 4 Exclusion Criteria: * Patients under legal guardianship or conservatorship * Patients without social security coverage * Pregnant patients * Patients with pre-existing immunosuppression: active solid cancer or cancer in remission for \< 5 years, active hematologic disease or in remission for \< 5 years, systemic disease (including in the absence of specific treatment), patient who has received a solid organ transplant or allogeneic bone marrow transplant, patient with HIV infection * Patients on immunosuppressants (including inhaled corticosteroids) or scheduled to receive postoperative immunosuppressive therapy * Patients on dual antiplatelet therapy * Patients with thrombocytopenia (less than 50 G/L) * Patients with a coagulopathy * Patients on oxygen therapy * Patients on amines * Patients on cardiac support * Patients scheduled for the following surgeries: * Aortic arch surgery * Aortic repair surgery * Adult congenital heart surgery * Structural cardiology (TAVI, MitraClip) * Long-term assist device surgery * Patients on AME

Locations (1)

Pitié-Salpêtrière Hospital - Institute of Cardiology

Paris, France