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NCT Number: NCT07598682

Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery

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.

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Key information

Conditions

Coronary Artery Bypass Grafting Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Acute Kidney Injury Postoperative Complications Risk Stratification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location contact

Gürcan Güler

CONTACT

[email protected]

+90 541 975 0407

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Postoperative Phenotype Classification

Other

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 outcomes

  1. 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

    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.

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: 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.

  2. In-Hospital Mortality

    Time frame: 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.

  3. Reintubation

    Time frame: 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.

  4. Arrhythmia Requiring Treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gürcan Güler

CONTACT

[email protected]

+90 541 975 0407

Gürcan Güler

CONTACT

[email protected]

+90 541 975 04 07

Sponsors and collaborators

Lead sponsor

Bursa Sevket Yilmaz Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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