An observational study in Cardiac Surgery Under Extra Corporeal Circulation, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 100 is below the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥ 18 years of age) scheduled to undergo elective cardiac surgery with cardiopulmonary bypass who have one or more risk factors for postoperative respiratory complications.
Who meets at least 1 major criterion or 2 minor criteria :
Major criteria :
Minor criteria :
Exclusion Criteria:
Patients scheduled for the following surgeries:
Blood samples and bronchoalveolar lavage (BAL) fluid will be collected on Day 0 (the day of the procedure), Day 1, and Day 2 from patients scheduled to undergo cardiac surgery with cardiopulmonary bypass.
Other: Blood sample collection · Other: Bronchoalveolar lavage fluid 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 (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)
Differential gene expression (log2 fold change) and pathway enrichment of peripheral blood mononuclear cells measured by single-cell RNA sequencing.
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.
Time frame: Day 0 (preoperative) - day 1 - day 2
Plasma concentrations of inflammatory biomarkers.
Plasma concentrations (relative log2-scaled units) of inflammatory cytokines and biomarkers of epithelial and endothelial injury will be measured using an Olink proteomic platform, and compared between groups.
Time frame: Day 0 (preoperative and postoperative) - day 1 - day 2
Bronchoalveolar lavage concentrations of inflammatory biomarkers
Inflammatory biomarker concentrations in BAL will be quantified (pg/mL), using commercially available multiplex immunoassays, and compared between groups.
Time frame: Day 0 - preoperative and postoperative
Phenotype of blood and bronchoalveolar leukocyte populations measured by flow cytometry .
Blood and bronchoalveolar leukocytes populations will be characterized using commercially available flow cytometry panels. The phenotype and activation status (percentage, absolute counts and median fluorescence intensity) of neutrophils, monocytes, lymphocytes and alveolar macrophage will be quantified and compared between groups.
Time frame: Day 0 (preoperative and postoperative) - day 1 - day 2
Expression levels of Hypoxia-inducible factor 1alpha and its signaling pathway, compared between groups.
Time frame: Day 0 (preoperative and postoperative) - day 1 - day 2
Inflammatory biomarkers production by alveolar macrophage after stimulation by immune agonists.
Alveolar macrophage will be cultured and stimulated for 24 hours with different agonists (including LPS, IL-4 and IL-10), according to previously published experimental protocols. Inflammatory biomarkers production will be quantified (pg/mL) in supernatant, using commercially available multiplex immunoassays. The results will be compared between groups.
Time frame: Day 0 - preoperative and postoperative
Differential gene expression (log2 fold change) and pathway enrichment of alveolar leukocytes measured by single-cell RNA sequencing.
Alveolar leukocytes 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 (log 2FC) will be compared between groups.
Time frame: Day 0 - preoperative and postoperative
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris