Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery

Cardiac Output, Low Clinical Trial

Official title:

Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468657
• Other study ID #: ejection fraction
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: January 2, 2025

Study information

• Verified date: June 2024
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Engin ihsan turan, Specialist
• Phone: +905382431114
• Email: enginihsan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgeries, specifically coronary artery bypass grafting (CABG) and heart valve replacement. It spans surgeries performed between 2012 and 2022 at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patients are categorized into two groups based on their preoperative EF: those with preserved EF (≥50%) and those with reduced EF (<50%).

The primary aim is to assess how EF affects postoperative morbidity, mortality, hospital stay, and complications. Secondary aims include evaluating the development of postoperative arrhythmias, the need for vasopressors and inotropes, and transfusion requirements.

Data will be collected retrospectively from hospital records and electronic health systems. The study's findings are expected to provide insights into tailored perioperative and postoperative management strategies for patients with varying EF levels, ultimately improving clinical outcomes.

Description:

Primary Objective The primary objective of this study is to evaluate the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgery. Specifically, the study aims to analyze the effects of EF on postoperative morbidity and mortality rates, length of hospital stay, and postoperative complications.

Secondary Objectives Secondary objectives include assessing the development of arrhythmias in the postoperative period, the need for vasopressors and inotropes, and the requirement for transfusions.

Scope of the Study Time Frame The study will encompass cardiovascular surgeries performed between 2012 and 2022. This time frame is selected to obtain a sufficient data set and evaluate long-term outcomes.

Research Center The study will be conducted at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patient data from cardiovascular surgeries performed at this center will be analyzed.

Patient Population The study will include all patients who underwent cardiovascular surgery within the specified time frame and had preoperative ejection fraction (EF) measurements.

Study Design Group Formation

Patients will be divided into two main groups based on their preoperative EF values:

Preserved EF Group: Patients with an EF of 50 or above. Reduced EF Group: Patients with an EF below 50. Data to be Examined

The following postoperative data will be examined and compared between the two groups:

Development of Postoperative Arrhythmias: Whether patients develop arrhythmias in the postoperative period.

Vasopressor Requirement: The need for vasopressors in the postoperative period. Inotrope Requirement: Whether patients require inotropic support postoperatively.

Transfusion Requirement: The need for blood transfusions in the postoperative period.

Mortality: Survival rates of patients following surgery. Need for Revision Surgery: Whether patients require additional surgical interventions postoperatively.

Length of Stay in ICU: Duration of patients' stay in the intensive care unit. Total Hospital Stay: Overall length of hospital stay. Data Collection Method Data will be retrospectively collected from hospital records and electronic health record (EHR) systems.

This structured approach aims to comprehensively evaluate the clinical outcomes of patients with varying levels of ejection fraction undergoing major cardiovascular surgeries, thereby providing insights that can enhance patient management strategies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 610
• Est. completion date: January 2, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: Patients aged 18 years and older.

• Cardiovascular Surgery: Patients who have undergone cardiovascular surgeries such as coronary artery bypass grafting (CABG), valve surgery, aortic surgery, etc.

• Ejection Fraction (EF): Patients with documented EF measurements.

Exclusion Criteria:

• Age: Patients under 18 years of age.

• Non-Surgical Interventions: Patients undergoing procedures other than cardiovascular surgery.

• Incomplete Data: Patients without documented EF measurements or with missing clinical data.

• Pregnancy: Patients who are pregnant.

Related Conditions & MeSH terms

• Cardiac Output, Low

Intervention

Other:
• mortality rates
mortality rates

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality in 30 days	30 days