Postoperative pneumonia after coronary artery bypass grafting

The Impact of Nosocomial Pneumonia on the Outcome and Prognosis of Stable Coronary Artery Disease After Coronary Artery Bypass Grafting

This project will see if adults who develop non-ventilator hospital-acquired pneumonia after coronary artery bypass grafting have worse cardiopulmonary outcomes in the year after surgery than those who do not.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Locations: 1 site (Tomsk, Tomsk Oblast)
• Trial ID: NCT07476274 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, observational cohort at Tomsk NRMC comparing patients who develop non-ventilator-associated nosocomial pneumonia after CABG with those who do not. Participants receive clinical, laboratory (CBC, metabolic panel, cardiac, inflammatory, infectious, and endothelial biomarkers), functional (ECG, echocardiography, ultrasound, spirometry, cardiopulmonary exercise testing), and radiologic (chest X-ray/CT) examinations. The study is unblinded and follows patients to identify factors linked to early and one-year cardiopulmonary prognosis. Data will be analyzed to define phenotype differences and risk factors that could inform prevention and management of postoperative respiratory and cardiovascular complications.

Who should consider this trial

Good fit: Adults aged 18 or older who undergo CABG at the center, are transferred from intensive care to the general ward, have one or more risk factors for nosocomial pneumonia, and provide informed consent.

Not a fit: Patients with recent acute coronary syndrome, combined valve surgery, preoperative respiratory failure requiring support, tracheostomy, recent malignancy, participation in another clinical trial within three months, or life expectancy under one year are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, the findings could help identify patients at higher risk for cardiopulmonary complications after CABG and guide targeted prevention and follow-up.

How similar studies have performed: Previous research links pneumonia to worse cardiovascular outcomes generally, but the specific long-term cardiopulmonary impact of nosocomial pneumonia after CABG is largely unstudied, so this approach is relatively novel.

Eligibility criteria

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).

Where this trial is running

Tomsk, Tomsk Oblast

• Cardiology Research Institute of Tomsk NRMC — Tomsk, Tomsk Oblast, Russia (Recruiting)

Study contacts

• Principal investigator: Alla A. Boshchenko, MD, PhD — Cardiology Research Institute of Tomsk NRMC
• Study coordinator: Roman S. Timoshenko, MD

Conditions Coronary Artery Disease; Pneumonia Nosocomial; pneumonia; Coronary Artery Bypass Grafting; coronary artery disease