Clinical trial NCT06770738: Correlation of the EUROSCORE-II With POSPOM in Cardiac Surgery: A Single Center, Retrospective, Cross- Sectional Study
Official title: Correlation of the European System for Cardiac Operative Risk Evaluation-II (EUROSCORE-II) With Preoperative Score to Predict Post-Operative Mortality (POSPOM) in Cardiac Surgery: A Single Center, Retrospective, Cross- Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Cardiovascular Diseases
Cardiovascular Complication
Anesthesia
Perioperative/Postoperative Complications
Surgery
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: In cardiac surgery patients, due to the surgical burden combined with existing comorbidities, evaluating the preoperative clinical status of patients and predicting mortality rates has become an important issue of interest for clinicians. For this purpose, mortality has been predicted with various scoring systems.

EUROSCORE is a scoring system used worldwide that predicts preoperative mortality for patients undergoing cardiac surgery. POSPOM is a scoring system used for mortality prediction in all surgeries including cardiac surgery. In this study, patients who apply to Istanbul University-Cerrahpasa, Institute of Cardiology between 2020-2024 will be screened.The following will be recorded as postoperative complications: re-sternotomy due to bleeding, re-sternotomy due to mediastinitis, new transient ischemic attack (TIA) or cerebrovascular accident, need for hemofiltration or dialysis, use of an intra-aortic balloon pump, wound infection, sepsis, tracheostomy.

The aim of this study is to evaluate the power of POSPOM score in predicting in-hospital mortality in patients undergoing cardiac surgery and its correlation with EUROSCORE-II. Secondarily, it is aimed to investigate postoperative complications after cardiac surgery.

Detailed description: Cardiopulmonary bypass (CPB) provides ease of application for surgical procedures, but it causes the body to experience some non-physiological events. With the CPB, various mechanisms are activated by converting pulsatile blood flow to laminar flow, contact of blood and tissues with the artificial surface of the CPB circuit, cardiac cold ischemia and hypothermia in the body. With the endothelial activation caused by the inflammatory response, changes occur in leukocytes, platelets, complement system activation and coagulation cascade. As a result; intraoperative and postoperative morbidity and mortality increase with systemic inflammatory response syndrome.

In cardiac surgery patients, due to the surgical burden combined with existing comorbidities, evaluating the preoperative clinical status of patients and predicting mortality rates has become an important issue of interest for clinicians. For this purpose, mortality has been predicted with various scoring systems.

European System for Cardiac Operative Risk Evaluation-II (EUROSCORE-II) is a scoring system that is specifically designed for patients undergoing cardiac surgery and is widely used worldwide to predict mortality through preoperative evaluation. Recent studies in the literature have reported that the sensitivity of EUROSCORE-II scoring may be low in older patients (over 70 and 80 years of age). Preoperative risk assessment is important in determining treatment plans for patients undergoing surgery, providing patient education for the postoperative period, providing insight into prognosis, and determining healthcare quality standards. A scoring system with higher predictive power is targeted by making modifications to EUROSCORE-II or by making comparisons with other scoring systems.

PreOperative Scores to Predict Post- Operative Mortality (POSPOM), defined by Le Manach et al. in 2016, is a useful scoring system that can be used for all types of surgery and can predict postoperative mortality with preoperative evaluation of patients. POSPOM includes parameters that evaluate the patient's age, the type of surgery to be performed, and the patient's comorbidities. There are various studies that have been applied to patients with hip fracture, radical cystectomy, uro -oncological surgery, and non -cardiac vascular surgery.

In this study, patients who apply to Istanbul University-Cerrahpasa, Institute of Cardiology between 2020-2024 will be screened. Patients aged 18 and over, patients who have CABG (Coronary artery bypass grafting) surgery, valve surgery or both, and patients with on-pump surgery will be included in the study. Patients under the age of 18, patients with off-pump surgery, and patients with non-cardiac vascular surgery will be excluded from the study. The following will be recorded as postoperative complications; re-sternotomy due to bleeding, re-sternotomy due to mediastinitis, new transient ischemic attack (TIA) or cerebrovascular accident, need for hemofiltration or dialysis, use of an intra-aortic balloon pump, wound infection, sepsis, tracheostomy.

The primary aim of the study is to evaluate the power of the POSPOM score in predicting in-hospital mortality in patients undergoing cardiac surgery and its correlation with EUROSCORE-II. Secondarily, it is aimed to investigate postoperative complications after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: In-hospital mortality in patients undergoing cardiac surgery
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative complications of cardiac surgery patients.
timeFrame: 15 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Professor
name: Kerem Erkalp, Dr
role: PRINCIPAL_INVESTIGATOR
References: