Immune Responses and Pulmonary Complications After Cardiac Surgery With Cardiopulmonary Bypass

NCT07865533 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2026-11

Last updated

2026-10-08

Condition(s) studied

Cardiac Surgery Under Extra Corporeal Circulation

Investigational drug(s) / intervention(s)

Blood sample collectionBronchoalveolar lavage fluid collection

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.

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)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Differential gene expression (log2 fold change) and pathway enrichment of peripheral blood mononuclear cells measured by single-cell RNA sequencing. — Day 0 (preoperative) - day 1 - day 2
Transcriptomic profile of peripheral blood mononuclear cells in relation to the development of postoperative respiratory complications following cardiac surgery with cardiopulmonary bypass. Peripheral blood mononuclear cells (PBMCs) harvested before and after surgery will be analyzed using a commercially available single-cell RNA sequencing platform. Differential expression of immune-related genes and transcriptional pathways (log2 FC) will be compared between groups.

Trial sites (1)

Facility	City	Region	Status
Pitié-Salpêtrière Hospital - Institute of Cardiology	Paris	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07865533 on ClinicalTrials.gov ↗ ← All trials in France