[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659497":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":27,"studyPopulation":37,"armGroups":38,"interventions":45,"overallOfficials":54,"centralContacts":64,"locations":73,"responsibleParty":88,"collaborators":90,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":27,"enrollmentInfo":109,"targetDuration":27,"studyType":112,"phases":27,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":123,"whyStopped":27,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nPeripheral 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.","Day 0 (preoperative) - day 1 - day 2",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"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.","Day 0 (preoperative and postoperative) - day 1 - day 2",{"measure":19,"description":20,"timeFrame":21},"Bronchoalveolar lavage concentrations of inflammatory biomarkers","Inflammatory biomarker concentrations in BAL will be quantified (pg\u002FmL), using commercially available multiplex immunoassays, and compared between groups.","Day 0 - preoperative and postoperative",{"measure":23,"description":24,"timeFrame":17},"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.",{"measure":26,"description":27,"timeFrame":17},"Expression levels of Hypoxia-inducible factor 1alpha and its signaling pathway, compared between groups.",null,{"measure":29,"description":30,"timeFrame":21},"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\u002FmL) in supernatant, using commercially available multiplex immunoassays. The results will be compared between groups.",{"measure":32,"description":33,"timeFrame":21},"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.",{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":35,"timePerspective":36,"maskingInfo":27},"COHORT","PROSPECTIVE","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.",[39],{"label":40,"type":27,"description":41,"interventionNames":42},"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.",[43,44],"Other: Blood sample collection","Other: Bronchoalveolar lavage fluid collection",[46,50],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":27},"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.",[40],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":27},"Bronchoalveolar lavage fluid collection","Bronchoalveolar lavage (BAL) fluid collection will be performed on Day 0:\n\n* 1 BAL under general anesthesia after induction of anesthesia and before the start of the surgical procedure\n* 1 BAL under general anesthesia after the surgical procedure, upon arrival in the intensive care unit (4 hours after aortic clamping is released)",[40],[55,58,61],{"name":56,"affiliation":5,"role":57},"Aurélie CAMPEANU","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":5,"role":60},"Benjamin Glenn CHOUSTERMAN, MD, PhD","STUDY_CHAIR",{"name":62,"affiliation":5,"role":63},"Adrien BOUGLE, MD, PhD","STUDY_DIRECTOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":27,"email":69},"Aurélie CAMPEANU, MD","CONTACT","+33184828252","aurelie.campeanu@aphp.fr",{"name":59,"role":67,"phone":71,"phoneExt":27,"email":72},"+33149958515","benjamin.chousterman@aphp.fr",[74],{"facility":75,"status":27,"city":76,"state":27,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Pitié-Salpêtrière Hospital - Institute of Cardiology","Paris","75013","France","FR",{"type":81,"coordinates":82},"Point",[83,84],2.3488,48.85341,{"lat":84,"lon":83},[87],{"name":56,"role":67,"phone":68,"phoneExt":27,"email":69},{"type":89,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[91,93,96],{"name":92,"class":6},"Université Paris Cité",{"name":94,"class":95},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"name":97,"class":98},"MASCOT, F-75006 Paris, France","UNKNOWN","100659497","immune-responses-and-pulmonary-complications-after-cardiac-surgery-with-cardiopulmonary-bypass-100659497",false,"NCT07865533","Immune Responses and Pulmonary Complications After Cardiac Surgery With Cardiopulmonary Bypass","A Study of the Association Between Pulmonary and Systemic Immuno-inflammation and Respiratory Complications Following Cardiac Surgery With Cardiopulmonary Bypass.","IIRIS","Inclusion Criteria :\n\n* Adult patient\n* Who has undergone cardiac surgery with cardiopulmonary bypass\n* Who has undergone elective surgery scheduled at least 48 hours in advance\n* Who meets at least 1 major criterion or 2 minor criteria :\n\n  * Major criteria :\n\n    * EuroSCORE II ≥ 5%\n    * Moderate to severe COPD (FEV1 \\\u003C 80% predicted and FEV1\u002FFVC \\\u003C 0.70) or PaCO2 \\> 45 mmHg\n    * BMI ≥ 35 kg\u002Fm²\n    * Confirmed sleep apnea syndrome (apnea-hypopnea index ≥ 15\u002Fh) or STOP-Bang score ≥ 5 or documented non-compliance with CPAP\n    * Significant pulmonary hypertension (systolic pulmonary arterial pressure ≥ 50 mmHg or Mean pulmonary arterial pressure ≥ 20 mmHg)\n    * Redux surgery or combined procedure (surgery on multiple valves or valve surgery combined with coronary artery bypass grafting)\n  * Minor criteria :\n\n    * Age ≥ 70 years\n    * BMI ≥ 30 kg\u002Fm² and \\\u003C 35 kg\u002Fm²\n    * Current smoking (≥ 10 pack-years)\n    * Restrictive respiratory failure (FVC \\\u003C 70% or parietal-thoracic pathology)\n    * LVEF \\\u003C 40%\n    * Chronic kidney disease (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m²)\n    * Frailty score ≥ 4\n\nExclusion Criteria:\n\n* Patients under legal guardianship or conservatorship\n* Patients without social security coverage\n* Pregnant patients\n* Patients with pre-existing immunosuppression: active solid cancer or cancer in remission for \\\u003C 5 years, active hematologic disease or in remission for \\\u003C 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\n* Patients on immunosuppressants (including inhaled corticosteroids) or scheduled to receive postoperative immunosuppressive therapy\n* Patients on dual antiplatelet therapy\n* Patients with thrombocytopenia (less than 50 G\u002FL)\n* Patients with a coagulopathy\n* Patients on oxygen therapy\n* Patients on amines\n* Patients on cardiac support\n* Patients scheduled for the following surgeries:\n\n  * Aortic arch surgery\n  * Aortic repair surgery\n  * Adult congenital heart surgery\n  * Structural cardiology (TAVI, MitraClip)\n  * Long-term assist device surgery\n* Patients on AME","ALL","18 Years",{"count":110,"type":111},100,"ESTIMATED","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.\n\nThis prospective observational cohort study will enroll 100 adult patients scheduled for elective cardiac surgery with CPB.\n\nThe 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.\n\nTo identify these profiles, blood and bronchoalveolar lavage samples will be collected at 5 (T0 -T4) and 2 (T0-T1) different times respectively.\n\nMultiple biological analyses (RNA single cell, proteomics, flow cytometry, cell culture experiments) will be performed to characterize the immune and inflammatory response to the surgery.\n\nPPCs are defined as atelectasis associated with hypoxemia (PaO2\u002FFiO2 \\\u003C 200), pneumonia or acute respiratory distress syndrome.\n\nThe study hypothesis is that patients who develop PPCs have a different immune and inflammatory response to cardiac surgery with CPB.",[115],"Cardiac Surgery Under Extra Corporeal Circulation",[117,118,119,120,121,122],"pulmonary inflammation","respiratory complications","systemic inflammation","cardiac surgery","extra corporeal circulation","ischemia-reperfusion","NOT_YET_RECRUITING","2026-10-04",{"date":126,"type":127},"2026-10-08","ACTUAL",{"date":129,"type":111},"2026-11",{"date":131,"type":111},"2028-07",{"name":5,"class":6},1]