Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery
Early Postoperative Trajectory-Based Phenotyping Improves Risk Stratification Beyond EuroSCORE in Patients Undergoing Coronary Artery Bypass Grafting
Coronary artery bypass grafting is a commonly performed heart surgery, but patients may have different risks for postoperative complications even when their preoperative risk scores are similar. EuroSCORE II is widely used to estimate surgical risk before cardiac surgery, but it may not fully reflect how the body responds during the early postoperative period.
This retrospective observational study will evaluate adult patients who underwent elective coronary artery bypass grafting with cardiopulmonary bypass between January 1, 2022 and December 31, 2025. The study will use existing hospital records and laboratory data. No additional treatment, test, or intervention will be given to patients as part of this study.
The main aim is to examine whether early postoperative changes in inflammatory and renal laboratory markers can identify different patient subgroups, called phenotypes. These markers include neutrophil-to-lymphocyte ratio, systemic immune-inflammation index, triglyceride-glucose index, and serum creatinine. The study will evaluate whether these phenotype groups are associated with postoperative acute kidney injury and prolonged intensive care unit stay.
The study will also assess whether this early postoperative phenotype-based classification provides additional risk information beyond EuroSCORE II.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-center retrospective observational cohort study designed to evaluate the prognostic relevance of early postoperative trajectory-based biological phenotyping in adult patients undergoing elective coronary artery bypass grafting with cardiopulmonary bypass.
The study population will include patients operated between January 1, 2022 and December 31, 2025. Data will be obtained retrospectively from hospital information systems, electronic medical records, laboratory databases, and archived patient files. All data will be anonymized before analysis, and no patient-identifying information will be included in the study dataset.
The study will collect demographic characteristics, comorbidities, preoperative clinical variables, EuroSCORE II, perioperative variables such as cardiopulmonary bypass time and aortic cross-clamp time, and laboratory parameters. Early postoperative laboratory values from postoperative day 0 and postoperative day 1 will be used to calculate inflammatory and metabolic indices, including neutrophil-to-lymphocyte ratio, systemic immune-inflammation index, and triglyceride-glucose index. Serum creatinine changes will be used to evaluate renal response and postoperative acute kidney injury.
Patients will be classified into phenotypic subgroups using unsupervised clustering methods based on early postoperative biomarker trajectories. The clinical characteristics and outcomes of these subgroups will then be compared. The main outcomes of interest are postoperative acute kidney injury and prolonged intensive care unit stay. Additional analyses will assess whether phenotype classification improves risk stratification beyond EuroSCORE II.
The study does not involve any intervention, experimental treatment, additional laboratory testing, or change in clinical care. All analyses will be performed using previously recorded clinical and laboratory data.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gürcan Güler
- Número de teléfono: +90 541 975 0407
- Correo electrónico: gurcanguler.45@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Gürcan Güler
- Número de teléfono: +90 541 975 04 07
- Correo electrónico: gurcanguler.45@gmail.com
Ubicaciones de estudio
-
-
-
Bursa, Turquía (Türkiye)
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
-
Contacto:
- Gürcan Güler
- Número de teléfono: +90 541 975 0407
- Correo electrónico: gurcanguler.45@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients who underwent elective on-pump coronary artery bypass grafting
- Patients operated between January 1, 2022 and December 31, 2025
- Patients with available perioperative clinical and laboratory data required for analysis
Exclusion Criteria:
- Patients undergoing emergency surgery
- Patients undergoing concomitant valve surgery
- Patients with missing or inconsistent key clinical or laboratory data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Elective CABG Cohort
Adult patients who underwent elective coronary artery bypass grafting with cardiopulmonary bypass between January 1, 2022 and December 31, 2025.
Patients will be included retrospectively from hospital records, electronic medical records, laboratory databases, and archived patient files.
No intervention, experimental treatment, or additional testing will be performed as part of this study.
|
Patients will be retrospectively classified into phenotype groups based on early postoperative inflammatory and renal biomarker trajectories.
This classification is analytical only and does not involve any intervention, treatment assignment, or additional testing.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Prolonged Postoperative Intensive Care Unit Stay
Periodo de tiempo: From surgery to intensive care unit discharge, assessed up to 30 days after surgery
|
Prolonged postoperative intensive care unit stay was defined as an intensive care unit length of stay exceeding 4 days after elective on-pump coronary artery bypass grafting.
|
From surgery to intensive care unit discharge, assessed up to 30 days after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute Kidney Injury
Periodo de tiempo: Within the first 72 hours after surgery
|
Postoperative acute kidney injury defined according to serum creatinine-based KDIGO criteria within the first 72 hours after elective on-pump coronary artery bypass grafting.
|
Within the first 72 hours after surgery
|
|
In-Hospital Mortality
Periodo de tiempo: From surgery until hospital discharge, assessed up to 30 days after surgery
|
Death from any cause occurring after elective on-pump coronary artery bypass grafting.
|
From surgery until hospital discharge, assessed up to 30 days after surgery
|
|
Reintubation
Periodo de tiempo: From surgery until hospital discharge, assessed up to 30 days after surgery
|
Requirement for endotracheal reintubation after initial postoperative extubation following elective on-pump coronary artery bypass grafting.
|
From surgery until hospital discharge, assessed up to 30 days after surgery
|
|
Arrhythmia Requiring Treatment
Periodo de tiempo: From surgery until hospital discharge, assessed up to 30 days after surgery
|
Occurrence of postoperative arrhythmia requiring medical treatment, electrical cardioversion, or another clinically documented therapeutic intervention after elective on-pump coronary artery bypass grafting.
|
From surgery until hospital discharge, assessed up to 30 days after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gürcan Güler, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Koyuncu AO, Yesiltas MA, Özsoy SD, Mert AM. Comparison of Systemic Inflammation Indices With Post-Cardiac Surgery Mortality and Morbidity. Heart Surg Forum. 2025 Sep 26;28(9). doi:10.31083/HSF46933
- Magouliotis DE, Sicouri N, Ramlawi L, Baudo M, Androutsopoulou V, Sicouri S. Artificial Intelligence in Adult Cardiovascular Medicine and Surgery: Real-World Deployments and Outcomes. J Pers Med. 2026 Jan 30;16(2):69. doi: 10.3390/jpm16020069.
- Silverborn M, Nielsen S, Karlsson M. The performance of EuroSCORE II in CABG patients in relation to sex, age, and surgical risk: a nationwide study in 14,118 patients. J Cardiothorac Surg. 2023 Jan 19;18(1):40. doi: 10.1186/s13019-023-02141-4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-TBEK 2026/05-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .