Nosocomial Pneumonia After Coronary Artery Bypass Grafting
NCT07476274
Summary
Observational studies of patients with coronary artery bypass grafting, associated with an unfavorable cardiopulmonary prognosis for at least one year after surgery. This is Prospective, cohort, unblinded, observational comparable single center clinical trial. To compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients with coronary artery bypass grafting with and without non-ventilator-associated postoperative, nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis. Increased risk of cardiovascular outcomes is related with the circulatory arrest, artificial circulation, perioperative trauma and respiratory complications of the postoperative period associating to the different severity and duration of the systemic inflammatory response, immune status disorders, hemostasis disorder, endothelial dysfunction, external respiration dysfunction, anatomic and functional disorders in the heart and lungs. Individual predictors of an unfavorable prognosis can be determined at the stage of before and just after surgery to conduct personalized prevention. This study aimed to compare the clinical, laboratory (including complete blood count, metabolic panel, and specific cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiological (chest X-ray/CT) phenotypes in patients after coronary artery bypass grafting with and without non-ventilator-associated postoperative nosocomial pneumonia; to identify the factors of early and 1-years cardiopulmonary prognosis.
Eligibility
Inclusion Criteria: * Age 18 years and older. * Myocardial revascularization for CAD via CABG during the current hospitalization, in accordance with the indications defined by the ESC/EACTS Guidelines on Myocardial Revascularization \[DOI: 10.1093/eurheartj/ehy394\]. * Successful transfer from the intensive care unit to a general ward after surgery. * One or more of the risk factor for nosocomial pneumonia \[doi: 10.15829/1560-4071-2024-6094\]. * Signed informed consent for participation in the study. Pre-operative Exclusion Criteria: * Acute coronary syndrome within the last 1 month. * Combined surgical intervention for infective endocarditis. * Combined valve surgery. * Concomitant pulmonary disease requiring respiratory support prior to surgery. * Presence of a tracheostomy. * Participation in another clinical trial at the time of potential inclusion or within the preceding 3 months. * Diagnosis of malignant neoplasms within the last 5 years. * Life duration of less than 1 year. * HIV infection. Peri-operative Exclusion Criteria: * Ventilator-Associated Pneumonia (VAP). * Acute Myocardial Infarction after CABG and before inclusion. * Acute Stroke after CABG and before inclusion. * Pulmonary after CABG and before inclusion. * Pulmonary Edema after CABG and before inclusion. * Acute Respiratory Distress Syndrome (ARDS) after CABG and before inclusion. * Pneumothorax requiring drainage after CABG and before inclusion. * Delirium after CABG and before inclusion. * Chronic Kidney Disease (CKD) Stage 4-5 / Acute Kidney Injury requiring renal replacement therapy or chronic dialysis. * Any perioperative complication requiring the patient's return to the intensive care unit or prolonging the ICU stay beyond 48 hours. * Any other active infectious process at a different site. * Novel Coronavirus Infection (COVID-19).
Conditions3
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NCT07476274