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Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery

13 mai 2026 mis à jour par: Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

1000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Bursa, Turquie (Türkiye)
        • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population will consist of adult patients who underwent elective on-pump coronary artery bypass grafting at University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital between January 1, 2022 and December 31, 2025. Eligible patients will be identified retrospectively from electronic medical records, laboratory databases, and archived patient files.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Prolonged Postoperative Intensive Care Unit Stay
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acute Kidney Injury
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Gürcan Güler, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

7 mai 2026

Achèvement primaire (Estimé)

1 juillet 2026

Achèvement de l'étude (Estimé)

1 juillet 2026

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

13 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because the study uses retrospective clinical and laboratory data obtained from hospital records. Although the dataset will be anonymized before analysis, data sharing is not planned due to institutional data privacy regulations and the retrospective nature of the study.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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