NCT07598682

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 7, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 7, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Coronary artery bypass graftingPostoperative phenotypingEuroSCORE IIRisk stratification

Outcome Measures

Primary Outcomes (1)

  • 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.

    From surgery to intensive care unit discharge, assessed up to 30 days after surgery

Secondary Outcomes (4)

  • Acute Kidney Injury

    Within the first 72 hours after surgery

  • In-Hospital Mortality

    From surgery until hospital discharge, assessed up to 30 days after surgery

  • Reintubation

    From surgery until hospital discharge, assessed up to 30 days after surgery

  • Arrhythmia Requiring Treatment

    From surgery until hospital discharge, assessed up to 30 days after surgery

Study Arms (1)

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.

Other: Early Postoperative Phenotype Classification

Interventions

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.

Elective CABG Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients undergoing emergency surgery
  • Patients undergoing concomitant valve surgery
  • Patients with missing or inconsistent key clinical or laboratory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bursa, Turkey (Türkiye)

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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: 41745362BACKGROUND
  • 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: 36658617BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gürcan Güler

    University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician, Department of Anesthesiology and Reanimation

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 20, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations