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

NCT06468657 | Completed

• 1 other identifier: ejection fraction
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Output, Low

Outcome Measures

Primary Outcomes (1)

• mortality

  mortality in 30 days

  30 days

Study Arms (2)

reduced ejection fraction

EF below 50

Other: mortality rates

preserved ejection fraction

EF above 50

Other: mortality rates

Interventions

mortality rates OTHER

mortality rates

Also known as: vasopressor/inotropic agent needs, transfusion needs, perioperative arrhythmias, intensive care stay

preserved ejection fraction; reduced ejection fraction

Eligibility Criteria

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

Study Population

A minimum of 210 patients who underwent cardiovascular surgery at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital and had their ejection fraction (EF) measured in the preoperative period will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Mortality; Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Engin ihsan Turan, Specialist

  Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 2, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)