- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07598682
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gürcan Güler
- Numer telefonu: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Gürcan Güler
- Numer telefonu: +90 541 975 04 07
- E-mail: gurcanguler.45@gmail.com
Lokalizacje studiów
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Bursa, Turcja (Türkiye)
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
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Kontakt:
- Gürcan Güler
- Numer telefonu: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Prolonged Postoperative Intensive Care Unit Stay
Ramy czasowe: From surgery to intensive care unit discharge, assessed up to 30 days after surgery
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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.
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From surgery to intensive care unit discharge, assessed up to 30 days after surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Acute Kidney Injury
Ramy czasowe: Within the first 72 hours after surgery
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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.
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Within the first 72 hours after surgery
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In-Hospital Mortality
Ramy czasowe: From surgery until hospital discharge, assessed up to 30 days after surgery
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Death from any cause occurring after elective on-pump coronary artery bypass grafting.
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From surgery until hospital discharge, assessed up to 30 days after surgery
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Reintubation
Ramy czasowe: From surgery until hospital discharge, assessed up to 30 days after surgery
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Requirement for endotracheal reintubation after initial postoperative extubation following elective on-pump coronary artery bypass grafting.
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From surgery until hospital discharge, assessed up to 30 days after surgery
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Arrhythmia Requiring Treatment
Ramy czasowe: From surgery until hospital discharge, assessed up to 30 days after surgery
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Occurrence of postoperative arrhythmia requiring medical treatment, electrical cardioversion, or another clinically documented therapeutic intervention after elective on-pump coronary artery bypass grafting.
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From surgery until hospital discharge, assessed up to 30 days after surgery
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Gürcan Güler, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2024-TBEK 2026/05-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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