Coronary Artery Bypass GraftingNCT07598682
Trajectory-Based Phenotyping After Coronary Artery Bypass Surgery
An observational study of Coronary Artery Bypass Grafting and Postoperative Acute Kidney Injury, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Postoperative Acute Kidney Injury, Postoperative Complications
- What is being tested?
- Early Postoperative Phenotype Classification
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients undergoing emergency surgery
- Patients undergoing concomitant valve surgery
- Patients with missing or inconsistent key clinical or laboratory data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Gürcan Güler, +90 541 975 0407, gurcanguler.45@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Bypass Grafting, Postoperative Acute Kidney Injury, Postoperative Complications, Risk Stratification
- Being tested
- Early Postoperative Phenotype Classification
- Keywords
- Coronary artery bypass grafting, Postoperative phenotyping, EuroSCORE II, Risk stratification
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Postoperative Phenotype ClassificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early Postoperative Phenotype Classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prolonged Postoperative Intensive Care Unit Stay
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.
Measured: From surgery to intensive care unit discharge, assessed up to 30 days after surgery
Secondary outcomes (4)
Acute Kidney Injury
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.
Measured: Within the first 72 hours after surgery
In-Hospital Mortality
Death from any cause occurring after elective on-pump coronary artery bypass grafting.
Measured: From surgery until hospital discharge, assessed up to 30 days after surgery
Reintubation
Requirement for endotracheal reintubation after initial postoperative extubation following elective on-pump coronary artery bypass grafting.
Measured: From surgery until hospital discharge, assessed up to 30 days after surgery
Arrhythmia Requiring Treatment
Occurrence of postoperative arrhythmia requiring medical treatment, electrical cardioversion, or another clinically documented therapeutic intervention after elective on-pump coronary artery bypass grafting.
Measured: From surgery until hospital discharge, assessed up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start7 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital
- Investigators
- Gürcan Güler, Principal investigator, University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598682
- Sponsor's protocol ID
- 2024-TBEK 2026/05-02
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 41745362Silverborn 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.
PubMed 36658617
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Trajectory-Based Phenotyping Improves Risk Stratification Beyond EuroSCORE in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07598682
- Acronym / sponsor ID
- 2024-TBEK 2026/05-02
- Conditions
- Coronary Artery Bypass Grafting, Postoperative Acute Kidney Injury, Postoperative Complications, Risk Stratification
- Keywords
- Coronary artery bypass grafting, Postoperative phenotyping, EuroSCORE II, Risk stratification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research HospitalOther government
- Study start
- 7 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective CABG Cohort | – | Other: Early Postoperative Phenotype ClassificationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing emergency surgery
- Patients undergoing concomitant valve surgery
- Patients with missing or inconsistent key clinical or laboratory data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Postoperative Phenotype ClassificationPatients 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. | Other | Elective CABG Cohort |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- BackgroundKoyuncu 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
- Background: PubMed 41745362Magouliotis 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.
- Background: PubMed 36658617Silverborn 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gürcan Güler principal investigator
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Grafting and Postoperative Acute Kidney Injury, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gürcan Güler (+90 541 975 0407, gurcanguler.45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07598682, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.