RecruitingNot Applicable

Nosocomial Pneumonia After Coronary Artery Bypass Grafting

Russia80 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of combined cardiovascular+respiratory endpoint (percentage);

Timeframe: 12 months

Trial details

NCT IDNCT07476274

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Roman S. Timoshenko, MD

+79539244630 trs@cardio-tomsk.ru

View on ClinicalTrials.gov More Coronary Artery Disease trials