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Not yet recruiting NCT07598682

Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery

Observational Coronary Artery Bypass Grafting Postoperative Acute Kidney Injury Postoperative Complications Risk Stratification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Postoperative Phenotype Classification.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass Grafting, Postoperative Acute Kidney Injury, Postoperative Complications, Risk Stratification. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Early Postoperative Trajectory-Based Phenotyping Improves Risk Stratification Beyond EuroSCORE in Patients Undergoing Coronary Artery Bypass Grafting

Overview

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.

Detailed description

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.

Interventions

  • Other Early Postoperative Phenotype Classification
    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.

Primary outcome measures

  • Number of Participants With Prolonged Postoperative Intensive Care Unit Stay [Time frame: From surgery to intensive care unit discharge, assessed up to 30 days after surgery]
Secondary outcome measures (4)
  • Acute Kidney Injury [Time frame: Within the first 72 hours after surgery]
  • In-Hospital Mortality [Time frame: From surgery until hospital discharge, assessed up to 30 days after surgery]
  • Reintubation [Time frame: From surgery until hospital discharge, assessed up to 30 days after surgery]
  • Arrhythmia Requiring Treatment [Time frame: From surgery until hospital discharge, assessed up to 30 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital — Bursa

Publications

  • 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. PMID 41745362
  • 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. PMID 36658617

Identifiers

NCT: NCT07598682 · 2024-TBEK 2026/05-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗