- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Gürcan Güler
- Telefonszám: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Gürcan Güler
- Telefonszám: +90 541 975 04 07
- E-mail: gurcanguler.45@gmail.com
Tanulmányi helyek
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Bursa, Törökország (Türkiye)
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
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Kapcsolatba lépni:
- Gürcan Güler
- Telefonszám: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
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-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
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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.
|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Number of Participants With Prolonged Postoperative Intensive Care Unit Stay
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Acute Kidney Injury
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Gürcan Güler, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2024-TBEK 2026/05-02
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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