Cardiac Output, LowNCT06468657
Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery
An observational study of Cardiac Output, Low, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- mortality rates
- How many people
- 610 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303
About this study
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.
Read the detailed 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.
- Conditions
- Cardiac Output, Low
- Being tested
- mortality rates
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mortality ratesOther
Also called vasopressor/inotropic agent needs, transfusion needs, perioperative arrhythmias, intensive care stay
mortality rates
| Study group | Role | What they receive |
|---|---|---|
| reduced ejection fraction | EF below 50 Receives: Other: mortality rates | |
| preserved ejection fraction | EF above 50 Receives: Other: mortality rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality in 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Engin ihsan Turan, Specialist, Principal investigator, Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468657
- Sponsor's protocol ID
- ejection fraction
- Status last verified
- Oct 2024
- First submitted
- 15 Jun 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT06468657
- Acronym / sponsor ID
- ejection fraction
- Conditions
- Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reduced ejection fraction | – | Other: mortality ratesEF below 50 |
| preserved ejection fraction | – | Other: mortality ratesEF above 50 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mortality ratesAlso: vasopressor/inotropic agent needs, transfusion needs, perioperative arrhythmias, intensive care staymortality rates | Other | preserved ejection fraction, reduced ejection fraction |
Primary outcome
mortality
Time frame: 30 days
mortality in 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engin ihsan Turan, Specialist principal investigator
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.