Nosocomial Pneumonia After Coronary Artery Bypass Grafting (CABG-PNEUM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Pneumonia Nosocomial
• Intervention / Treatment: Other: Clinical, laboratory, and instrumental examination

Detailed Description

RESEARCH RELEVANCE Cardiovascular diseases (CVD), remain the leading cause of death worldwide. In 2017, mortality from cardiovascular diseases reached 862,895 people, or 587.6 per 100,000 of the population. Coronary artery disease (CAD) holds the leading position in the structure of causes of death from CVD. The annual mortality rate from CAD is 27%, with 42% of all deceased being of working age. Myocardial revascularization is one of the most common surgical procedures for the effective treatment of CAD. In the United States, over 200,000 coronary artery bypass grafting (CABG) surgeries are performed annually, with approximately 14% of patients being rehospitalized within 30 days after discharge and another 10% visiting emergency departments due to surgery-related complications and care issues. Pulmonary complications, primarily pneumonia (3%-42%), account for a significant proportion of the complications. Although pneumonia primarily affects the lungs, growing evidence suggests that it can have a negative impact on many systems and organs, particularly the cardiovascular system. The impact of pneumonia on the starting CVD consist the most evidences. The short-term and long-term impact of nosocomial pneumonia (NP) on the course of determined CVD, especially following myocardial revascularization performed using coronary bypass grafting (CABG) has not been previously assessed, and potential mechanisms have not been studied. It is known that the CABG leads to an enhanced systemic inflammatory response, is associated with nitric oxide deficiency, endothelial dysfunction, and procoagulant activity. Therefore, a postoperative complication in the form of NP in patients with multivessel CAD and not rare anatomic and functional myocardial disorders could potentially lead to a short-term additive enhancement of the inflammatory and endothelial response associated with the surgery, and to long-term activation of immune inflammation after CABG. The consequence of this may be an increased frequency of any complications within one year or more after surgery and a reduction in its effectiveness in reversing signs of coronary and heart failure. However, there is no confirmation of this assumption. The impact of pneumonia complications, such as respiratory failure, on the course of stable CAD is also insufficiently studied.

The study will be conducted at the Cardiology Research Institute - a branch of the Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences" (Cardiology Research Institute of the Tomsk NRMC) in Tomsk, Russia, from December 2024 to June 2027. The study was approved by the Biomedical Ethics Committee of the Cardiology Research Institute of the Tomsk NRMC on December 25, 2024. Informed consent will be obtained from all study participants after the nature, purpose, and potential risks of the study have been explained to them.

PRIMARY OBJECTIVE To test the hypothesis that in patients with stable coronary artery disease undergoing CABG, the occurrence of postoperative nosocomial pneumonia is associated with an adverse cardiopulmonary prognosis for at least one year after surgery.

SRCONDARY OBJECTIVES To compare the clinical, cellular, secretory, and instrumental profiles, as well as their in-hospital dynamics, between patients with an uncomplicated postoperative course and those complicated by nosocomial pneumonia.

To assess the sensitivity, specificity, and diagnostic accuracy of pulmonary and systemic criteria for diagnosing nosocomial pneumonia in patients with CAD following surgical myocardial revascularization; to identify the most specific systemic diagnostic criteria or propose new ones.

In a prospective one-year follow-up study of patients with CAD corrected by CABG, to evaluate the impact of nosocomial pneumonia on cardiopulmonary prognosis; to identify in-hospital predictors of an unfavorable prognosis for the purpose of personalized prevention.

The effectiveness of the study will be assessed by such a concept as "end point".

The primary endpoint was assessed at visits 5, 6, and 7 as the difference in parameters between the groups with pneumonia and without pneumonia and included the frequency of occurrence of one or more cardiovascular and/or respiratory endpoint events.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Roman S. Timoshenko, MD; Phone Number: +79539244630; Email: trs@cardio-tomsk.ru

Study Locations

• Russia
  • Tomsk Oblast
    • Tomsk, Tomsk Oblast, Russia, 634012
      • Recruiting
      • Cardiology Research Institute of Tomsk NRMC
      • Contact: Roman S. Timoshenko, MD; Phone Number: +79539244630; Email: trs@cardio-tomsk.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main group with HAP after CABG; Patients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), complicated by postoperative nosocomial pneumonia.	Other: Clinical, laboratory, and instrumental examination; Clinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints.
Control group without HAP after CABG; Patients with coronary artery disease (CAD) after Coronary Artery Bypass Grafting (CABG), without postoperative nosocomial pneumonia.	Other: Clinical, laboratory, and instrumental examination; Clinical, laboratory, and instrumental examinations will be performed to achieve the specified primary and secondary endpoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of procalcitonin (ng/ml);	Difference between groups in the levels of procalcitonin;	12 months
Levels of interleukins 1 (pg/ml);	Difference between groups in the levels of interleukins 1.	12 months
Changes in immune status (in percent);	Difference between groups in the changes in immune status;	30 days
Level of endothelin-1 (ET-1) (pg/ml);	Difference between groups in the level of endothelin-1 (ET-1);	6 months
Level of presepsin (pg/ml);	Difference between groups in the levels of presepsin	6 months
Interleukins 6(pg/ml);	Difference between groups in the levels of interleukins 6;	6 months
Tumor Necrosis Factor α (TNF-α)(pg/ml);	Difference between groups in the levels of TNF-α;	6 months
Level of vascular endothelial growth factor (VEGF) (pg/ml);	Difference between groups in the level of vascular endothelial growth factor (VEGF);	6 months
Difference between groups in the level of endocan (pg/ml);	Level of endocan .	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (SBP) levels (mmHg);	Difference between groups in the levels of SBP	12 months
Level of NT-proBNP (N-terminal pro-B-type natriuretic peptide) (pg/ml);	Difference between groups in the NT-proBNP level;	6 months
Presence of life-threatening and symptomatic cardiac arrhythmias (in percent);	Difference between groups in the presence of life-threatening and symptomatic cardiac arrhythmias	12 months
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).	12 months
Level of Troponin I (ng/ml);	Difference between groups in the Troponin I level;	12 months
Heart failure class according to NYHA (New York Heart Association) (in percent);	Difference between groups in the Heart failure class according to NYHA	12 months
Result of calculating inflammatory indices/scores (in percent);	Difference between groups in the result of calculating inflammatory indices/scores;	12 months
Dynamics of ventilatory parameters during spiroergometry (in percent);	Difference between groups in the dynamics of ventilatory parameters during spiroergometry;	12 months
Severity of ventilatory impairments during spirometry (in percent);	Difference between groups in the severity of ventilatory impairments during spirometry;	12 months
Worsening of chronic heart failure by NYHA(New York Heart Association) Functional Class I or more during prospective follow-up (in percent);	Difference between groups in the worsening of CHF by NYHA Functional Class I or more during prospective follow-up; increase in dosage / initiation of diuretics; first-time prescription of antiarrhythmic drugs during prospective follow-up.	12 months
Exercise tolerance during spiroergometry (in percent);	Difference between groups in the exercise tolerance during spiroergometry.	6 months
Tiffeneau index (in percent);	Difference between groups in the Tiffeneau index,	12 months
Frequency of glucocorticoid prescription (in percent);	Difference between groups in the frequency of glucocorticoid prescription;	12 months
Frequency of transfer to the ICU (Intensive Care Unit) (in percent);	Difference between groups in the frequency of transfer to the ICU;	30 days
Frequency of sepsis/septic shock development (in percent);	Difference between groups in the frequency of sepsis and septic shock development.	12 months
Difference between groups in the onset of respiratory failure (RF) or its worsening by 1 grade or more (in percent);	Difference between groups in the onset of respiratory failure (RF) or its worsening by 1 grade or more during prospective follow-up;	12 months
Exercise duration during spiroergometry, achieved heart rate (in percent);	Difference between groups in the exercise duration during spiroergometry, achieved heart rate;	12 months
Level and dynamics of EQ-5D-5L quality of life questionnaire scores (in percent);	Difference between groups in the level and dynamics of EQ-5D-5L quality of life questionnaire scores;	12 months
Need for and duration of respiratory support (in percent);	Difference between groups in the need for and duration of respiratory support;	12 months
Level and dynamics of body temperature (°C);	Difference between groups in the level and dynamics of body temperature;	30 days
Prescription of inhaled bronchodilators (in percent);	Difference between groups in the prescription of inhaled bronchodilators for continuous use during prospective follow-up.	12 months
Forced expiratory volume (L/s);	Difference between groups in the forced expiratory volume is measured in liters per second (L/s).	12 months
Forced vital capacity (L)	Difference between groups in the forced vital capacity is measured in liters (L).	12 months
Vital capacity (L)	Difference between groups in the vital capacity is measured in liters (L).	12 months
The Six-Minute Walk test (6MWT) (in meters);	Difference between groups in the Six-Minute Walk test (6MWT)	12 months
Respiratory rate (RR) (bpm);	Difference between groups in the respiratory rate is measured in breaths per minute.	12 months
Length of hospital stay after surgery (days);	Difference between groups in the length of hospital stay after surgery;	30 days
Level of peripheral capillary oxygen saturation (SpO2) (in percent);	Difference between groups in the SpO2 levels	12 months
Medication adherence (in percent);	Difference between groups in the medication adherence;	12 months
Degree of respiratory failure (in percent);	Difference between groups in the degree of respiratory failure;	12 months
Any other postoperative complications (in percent);	Difference between groups in any other postoperative complications.	12 months
Right ventricular fractional area change (RVFAC) (in percent);	Difference between groups in the Right ventricular fractional area change (RVFAC);	12 months
Right ventricular systolic pressure (RVSP) (mmHg);	Difference between groups in the Right ventricular systolic pressure (RVSP);	12 months
Left Ventricular Global Longitudinal Strain (LV GLS) (in percent);	Difference between groups in the Left Ventricular Global Longitudinal Strain	12 months
Left ventricular end-diastolic volume index (EDVI);	Difference between groups in the left ventricular end-diastolic volume index (EDVI)	12 months
Angina Functional Class (in percent);	Difference between groups in the Angina Functional Class	12 months
Heart rate (HR) (bpm);	Difference between groups in heart rate is measured in beats per minute.	12 months
Diastolic blood pressure (DBP) Levels (mm Hg);	Difference between groups in the levels of DBP;	12 months
Left ventricular stroke index (SI) (in percent);	Difference between groups in the left ventricular stroke index (SI).	12 months
Left ventricular ejection fraction (LVEF) (in percent);	Difference between groups in the left ventricular ejection fraction (LVEF).	12 months
Wall motion score index (WMSI);	Difference between groups in the wall motion score index (WMSI);	12 months
Frequency of significant ST-segment depression during spiroergometry (in percent);	Difference between groups in the frequency of significant ST-segment depression during spiroergometry.	6 months
Depth and time of onset of ST-segment depression during spiroergometry (in percent);	Difference between groups in the depth of ST-segment depression during spiroergometry;	6 months
Time of onset of ST-segment depression during spiroergometry (in percent);	Difference between groups in the time of onset of ST-segment depression during spiroergometry;	6 months
Cardiac arrhythmias during spiroergometry (in percent);	Difference between groups in the cardiac arrhythmias during spiroergometry;	6 months
Increase in dosage / initiation of diuretics; first-time prescription of antiarrhythmic drugs during prospective follow-up (in percent);	Difference between groups in the increase in dosage / initiation of diuretics during prospective follow-up.	12 months
First-time prescription of antiarrhythmic drugs during prospective follow-up (in percent);	Difference between groups in the first-time prescription of antiarrhythmic drugs during prospective follow-up.	12 months
Level of the Medical Research Council (from 0 to 4) dyspnea scale;	Difference between groups in the level of the Medical Research Council (from 0 to 4) dyspnea scale. 0 - Not troubled by breathlessness except on strenuous exercise; - Short of breath when hurrying or walking up a slight hill; - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; - Stops for breath after walking about 100m or after a few minutes on level ground; - Too breathless to leave the house, or breathless when dressing or undressing	12 months

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Alla A. Boshchenko, MD, PhD, Cardiology Research Institute of Tomsk NRMC; Study Chair: Tatiana P Kalashnikova, MD, PhD, Cardiology Research Institute of Tomsk NRMC; Study Chair: Irina V. Kologrivova, MD, PhD, Cardiology Research Institute of Tomsk NRMC; Study Chair: Natalia V. Rebrova, MD, PhD, Cardiology Research Institute of Tomsk NRMC; Study Chair: Arina S Zinovieva, MD, Cardiology Research Institute of Tomsk NRMC; Study Chair: Ulia A Arseneva, MD, Cardiology Research Institute of Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; pneumonia; Coronary Artery Bypass Grafting
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Coronary Artery Disease; Health Care Facilities Workforce and Services; Non-Medical Public and Private Facilities; Health Facilities; Laboratories
• Other Study ID Numbers: CRI-274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• IPD Sharing Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No