Immune Responses and Pulmonary Complications After Cardiac Surgery With Cardiopulmonary Bypass
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patient
Who has undergone cardiac surgery with cardiopulmonary bypass
Who has undergone elective surgery scheduled at least 48 hours in advance
EuroSCORE II ≥ 5%
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sample collection
Other interventionBlood 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
Other interventionBronchoalveolar 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)
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients scheduled for cardiac surgery using cardiopulmonary bypass2 interventions
Trial outcomes
Primary outcomes
1
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 2Secondary outcomes
1
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 22
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 postoperative3
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 24
Expression levels of Hypoxia-inducible factor 1alpha and its signaling pathway, compared between groups.
Time frame
Day 0 (preoperative and postoperative) - day 1 - day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Université Paris Cité
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
MASCOT, F-75006 Paris, France
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: