Nosocomial Pneumonia After Coronary Artery Bypass Grafting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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].
Disqualifiers
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.
Trial population
Patient enrollment will take place at the Department of Atherosclerosis and Chronic Ischemic Heart Disease and the Department of Cardiovascular Surgery of the Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences (Cardiology Research Institute, Tomsk NRMC).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical, laboratory, and instrumental examination
Other interventionClinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Main group with HAP after CABG1 intervention
Group B: Control group without HAP after CABG1 intervention
Trial outcomes
Primary outcomes
1
Incidence of combined cardiovascular+respiratory endpoint (percentage);
The study will assess the incidence (percentage) of occurrence of combined cardiovascular+respiratory endpoint that includes the following events: * Cardiovascular events: All-cause mortality, cardiovascular mortality, acute myocardial infarction, unstable angina, myocardial revascularization, acute cerebrovascular accident, transient ischemic attack, hospitalization or emergency medical service visit for acute heart failure or decompensation of chronic heart failure, hospitalization for cardiac arrhythmias, new-onset atrial fibrillation. * Respiratory events: Respiratory mortality, hospitalization for broncho-obstructive or broncho-restrictive diseases, new oxygen dependence, initiation of non-invasive or invasive mechanical ventilation, new diagnosis of bronchial asthma or chronic obstructive pulmonary disease n the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.
Time frame
12 monthsSecondary outcomes
1
Levels of procalcitonin (ng/ml);
Difference between groups in the levels of procalcitonin;
Time frame
12 months2
Levels of interleukins 1 (pg/ml);
Difference between groups in the levels of interleukins 1.
Time frame
12 months3
Changes in immune status (in percent);
Difference between groups in the changes in immune status;
Time frame
30 days4
Level of endothelin-1 (ET-1) (pg/ml);
Difference between groups in the level of endothelin-1 (ET-1);
Time frame
6 monthsOther outcomes
1
Systolic blood pressure (SBP) levels (mmHg);
Difference between groups in the levels of SBP
Time frame
12 months2
Level of NT-proBNP (N-terminal pro-B-type natriuretic peptide) (pg/ml);
Difference between groups in the NT-proBNP level;
Time frame
6 months3
Presence of life-threatening and symptomatic cardiac arrhythmias (in percent);
Difference between groups in the presence of life-threatening and symptomatic cardiac arrhythmias
Time frame
12 months4
Severity of systemic inflammatory response syndrome manifestations (in percent);
Difference between groups in the severity of systemic inflammatory response syndrome manifestations (fever, leukocytosis, left shift in the leukocyte formula, categorized by phenotypes).
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov