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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04741555
Other study ID # 2020/295
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date June 1, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary neutrophil / lymphocyte ratios The effect on postoperative complications of preoperative neutrophil lymphocyte ratio in open heart surgery postoperative 2 week
Primary neutrophil / lymphocyte ratios The effect on mortality of preoperative neutrophil lymphocyte ratio in open heart surgery postoperative 1 year
Primary uric acid values The effect on mortality of preoperative uric acid values in open heart surgery postoperative 1 year
Primary uric acid values The effect on postoperative complications of preoperative uric acid values in open heart surgery postoperative 2 week
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