Cardiac Surgery Under Extra Corporeal CirculationIIRISNCT07865533
Immune Responses and Pulmonary Complications After Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Cardiac Surgery Under Extra Corporeal Circulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Under Extra Corporeal Circulation
- What is being tested?
- Blood sample collection and Bronchoalveolar lavage fluid collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 may be able to join
- 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%
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Pitié-Salpêtrière Hospital - Institute of Cardiology
Paris, 75013
Aurélie CAMPEANU, +33184828252, aurelie.campeanu@aphp.fr
About this study
Official title: A Study of the Association Between Pulmonary and Systemic Immuno-inflammation and Respiratory Complications Following Cardiac Surgery With Cardiopulmonary Bypass.
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.
Read more
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.
- Being tested
- Blood sample collection, Bronchoalveolar lavage fluid collection
- Keywords
- pulmonary inflammation, respiratory complications, systemic inflammation, cardiac surgery, extra corporeal circulation, ischemia-reperfusion
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
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 collectionOther
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 group | Role | What they receive |
|---|---|---|
| Patients scheduled for cardiac surgery using cardiopulmonary bypass | 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. Receives: Other: Blood sample collection; Other: Bronchoalveolar lavage fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (preoperative) - day 1 - day 2
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Day 0 (preoperative and postoperative) - day 1 - day 2
Expression levels of Hypoxia-inducible factor 1alpha and its signaling pathway, compared between groups.
Measured: 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.
Measured: 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.
Measured: Day 0 - preoperative and postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Under Extra Corporeal CirculationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris Cité, Institut National de la Santé Et de la Recherche Médicale, France, MASCOT, F-75006 Paris, France
- Responsible party
- Sponsor
- Investigators
- Aurélie CAMPEANU, Principal investigator, Assistance Publique - Hôpitaux de ParisBenjamin Glenn CHOUSTERMAN, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisAdrien BOUGLE, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865533
- Sponsor's protocol ID
- APHP260213
- Other IDs
- 2026-A00702-49
- Acronym
- IIRIS
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Association Between Pulmonary and Systemic Immuno-inflammation and Respiratory Complications Following Cardiac Surgery With Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT07865533
- Acronym / sponsor ID
- IIRIS / APHP260213
- Keywords
- pulmonary inflammation, respiratory complications, systemic inflammation, cardiac surgery, extra corporeal circulation, ischemia-reperfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Université Paris Cité, Institut National de la Santé Et de la Recherche Médicale, France, MASCOT, F-75006 Paris, France
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for cardiac surgery using cardiopulmonary bypass | – | Other: Blood sample collection, Other: Bronchoalveolar lavage fluid collectionBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (19 listed)
- 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 :
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood 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 | Patients scheduled for cardiac surgery using cardiopulmonary bypass |
| Bronchoalveolar lavage fluid collectionBronchoalveolar 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) | Other | Patients scheduled for cardiac surgery using cardiopulmonary bypass |
Primary outcome
Differential gene expression (log2 fold change) and pathway enrichment of peripheral blood mononuclear cells measured by single-cell RNA sequencing.
Time frame: 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.
6 secondary outcomes
Plasma concentrations of inflammatory biomarkers.
Time frame: Day 0 (preoperative and postoperative) - day 1 - day 2
Bronchoalveolar lavage concentrations of inflammatory biomarkers
Time frame: Day 0 - preoperative and postoperative
Phenotype of blood and bronchoalveolar leukocyte populations measured by flow cytometry .
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.
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.
Time frame: Day 0 - preoperative and postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie CAMPEANU principal investigator
Assistance Publique - Hôpitaux de Paris
Benjamin Glenn CHOUSTERMAN, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Adrien BOUGLE, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Under Extra Corporeal Circulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie CAMPEANU, MD (+33184828252, aurelie.campeanu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential gene expression (log2 fold change) and pathway enrichment of peripheral blood mononuclear cells measured by single-cell RNA sequencing. (time frame: Day 0 (preoperative) - day 1 - day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.