The Effect of Preoperative Values on Mortality in Patients Undergoing Open Heart Surgery

June 18, 2021 updated by: Ali AKDOĞAN, Karadeniz Technical University

The Effect of Preoperative Neutrophil / Lymphocyte Ratio and Uric Acid Values on Short and Long Term Mortality in Patients Undergoing Open Heart Surgery

Open heart surgeries are one of the major and complicated surgeries performed frequently in the world due to the prolongation of life expectancy and developments in medicine. As a result of these operations, not only the heart and vessels, but also all organs and systems depending on the systemic circulation are affected. Some biological inflammation markers have been determinant in determining cardiovascular risk. High neutrophil count was associated with increased mortality, while low lymphocyte count was a strong constant predictor of mortality. In addition, increased serum uric acid (UA) levels have been found to be associated with obesity, dyslipidemia, and hypertension, which is associated with cardiovascular disease risk. The aim of this study is to investigate the effects of patients who underwent coronary bypass surgery under elective conditions in Karadeniz Technical University Faculty of Medicine between 2008-2020 on in-hospital and 1-year mortality based on preoperative neutrophil / lymphocyte ratios and uric acid values.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Open heart surgeries are one of the major and complicated surgeries performed frequently in the world due to the prolongation of life expectancy and developments in medicine. Mortality rates are decreasing day by day, although more and more additional diseases are present and older patients are taken in open heart surgery. The aim of these surgeries is to reduce the risk of death by correcting existing cardiac pathologies and increasing the quality of life of patients. For this reason, some studies have developed cardiac risk scoring methods in preoperative evaluation in order to predict mortality before surgery, and created a risky group such as advanced age, female gender, decreased left ventricular functions, those who use postoperative intraaortic balloon pumps, and those who receive inotrope support.

Some biological inflammation markers have been determinant in determining cardiovascular risk. High neutrophil count was associated with increased mortality, while low lymphocyte count was a strong constant predictor of mortality. Cardiovascular bypass itself is related to neutrophil activation, highlighting the effects of its high preoperative levels. Increased neutrophil counts are related to blood viscosity and hypercoagulability. Also, decreased lymphocyte count indicates increased physiological stress.

The importance of serum uric acid levels has been stated in many epidemiological studies as a risk factor for cardiovascular diseases. Increased serum uric acid (UA) levels are associated with obesity, dyslipidemia, and hypertension, which is associated with a risk of cardiovascular disease. In another study, it was shown that the risk of cardiovascular mortality and increased serum UA levels were independently and significantly related.

The aim of this study was to examine the short-term (first 30 days) and long-term (1 year) mortality of patients who underwent elective coronary bypass surgery between 2008 and 2020 at the Karadeniz Technical University Faculty of Medicine, based on preoperative neutrophil / lymphocyte ratios and uric acid values. effects will be investigated

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study was planned as a retrospective (retrospective) study involving patients who underwent elective open heart surgery between January 1, 2008 and December 31, 2020

Description

Inclusion Criteria:

  • Elective patients undergoing open heart surgery

Exclusion Criteria:

  • Immunodeficiency
  • Emergency operations
  • Patients whose records could not be accessed and who were excluded from the study group procedure in which they were included for any reason will not be included in the study.
  • Patients under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
neutrophil / lymphocyte ratios
Time Frame: postoperative 2 week
The effect on postoperative complications of preoperative neutrophil lymphocyte ratio in open heart surgery
postoperative 2 week
neutrophil / lymphocyte ratios
Time Frame: postoperative 1 year
The effect on mortality of preoperative neutrophil lymphocyte ratio in open heart surgery
postoperative 1 year
uric acid values
Time Frame: postoperative 1 year
The effect on mortality of preoperative uric acid values in open heart surgery
postoperative 1 year
uric acid values
Time Frame: postoperative 2 week
The effect on postoperative complications of preoperative uric acid values in open heart surgery
postoperative 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/295

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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