EuroSCORE-II and POSPOM in Cardiac Surgery

NCT06770738 | Completed

• 1 other identifier: 017
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to compare the performances of the European System for Cardiac Operative Risk Evaluation (EuroSCORE-II) and the PreOperative Score to Predict Postoperative Mortality (POSPOM) in predicting in-hospital mortality among patients undergoing on-pump cardiac surgery, with further evaluation of discrimination, calibration, agreement, and clinical utility. This retrospective observational study will be conducted at a single tertiary university cardiac surgery centre. Adult patients (≥18 years) who underwent coronary artery bypass grafting, valve surgery, or combined procedures between 2020 and 2024 will be included. No experimental interventions will be applied. Preoperative EuroSCORE-II and POSPOM values will be calculated for all patients. Discrimination will be assessed using ROC and precision-recall curves with DeLong's test. Calibration will be evaluated using calibration-in-the-large, calibration slope, Hosmer-Lemeshow testing, and GiViTI calibration belts. Agreement will be analyzed using ICC, CCC, Bland-Altman plots, and Passing-Bablok and Deming regression. Subgroup analyses will be performed by age and sex.

Conditions

Cardiac Disease; Cardiovascular Diseases; Cardiovascular Complication; Anesthesia; Perioperative/Postoperative Complications; Surgery

Outcome Measures

Primary Outcomes (1)

• investigation whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery

  The primary objective of this study was to investigate whether the POSPOM score has sufficient predictive power for in-hospital mortality in patients undergoing cardiac surgery. Measure Type: Continuous Unit of Measure: ROC-AUC Minimum: 0.50 Maximum: 1.00 Description of Meaningful Outcome: Predictive performance will be considered clinically meaningful if the ROC-AUC of the POSPOM score for in-hospital mortality is significantly greater than 0.50.

  1 month

Secondary Outcomes (1)

• Correlation of EuroSCORE-II and POSPOM

  15 days

Study Arms (1)

Operation group

Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery in 2020-2024 will be included in the study. The sample size was calculated as 314 with an effect size of 0.2, 95% power and 0.05 error level using the G Power 3.1.9.2 package program, taking into account the study of Kaplan et al.

Other: There is no intervention in this study.

Interventions

There is no intervention in this study. OTHER

This study is planned as a retrospective study. Only the information of the patients will be used.

Operation group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In Turkish people including all genders at the age of 18-99 and was operated open heart surgery will be the study population.

You may qualify if:

• Patients aged 18 and over, patients who have CABG surgery, valve surgery or both, and patients with on-pump surgery will be included in the study.

You may not qualify if:

• Patients under the age of 18, patients with off-pump surgery, and patients with non-cardiac vascular surgery will be excluded from the study.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerem Erkalp, Dr

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 3, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 18, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TU (1)