Mechanical VentilationNCT04741555
The Effect of Preoperative Values on Mortality in Patients Undergoing Open Heart Surgery
An observational study of Mechanical Ventilation and Coronary Bypass Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Coronary Bypass Surgery, Postoperative Complications
- How many people
- 1,600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2021
- 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
- Adult, Older adult
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
Who may be able to join
- Elective patients undergoing open heart surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- neutrophil / lymphocyte ratios, uric acid level, mortality, coronary bypass surgery, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil / lymphocyte ratios
The effect on postoperative complications of preoperative neutrophil lymphocyte ratio in open heart surgery
Measured: postoperative 2 week
neutrophil / lymphocyte ratios
The effect on mortality of preoperative neutrophil lymphocyte ratio in open heart surgery
Measured: postoperative 1 year
uric acid values
The effect on mortality of preoperative uric acid values in open heart surgery
Measured: postoperative 1 year
uric acid values
The effect on postoperative complications of preoperative uric acid values in open heart surgery
Measured: postoperative 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jun 2020
- Primary completion15 Feb 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741555
- Sponsor's protocol ID
- 2020/295
- Status last verified
- Jun 2021
- First submitted
- 2 Feb 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Neutrophil / Lymphocyte Ratio and Uric Acid Values on Short and Long Term Mortality in Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT04741555
- Acronym / sponsor ID
- 2020/295
- Keywords
- neutrophil / lymphocyte ratios, uric acid level, mortality, coronary bypass surgery, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Feb 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Elective patients undergoing open heart surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neutrophil / lymphocyte ratios
Time frame: postoperative 2 week
The effect on postoperative complications of preoperative neutrophil lymphocyte ratio in open heart surgery
neutrophil / lymphocyte ratios
Time frame: postoperative 1 year
The effect on mortality of preoperative neutrophil lymphocyte ratio in open heart surgery
uric acid values
Time frame: postoperative 1 year
The effect on mortality of preoperative uric acid values in open heart surgery
uric acid values
Time frame: postoperative 2 week
The effect on postoperative complications of preoperative uric acid values in open heart surgery
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 21 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation and Coronary Bypass Surgery, run by Karadeniz Technical University 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 1 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 21 Jun 2021. 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?
neutrophil / lymphocyte ratios (time frame: postoperative 2 week). The study lists 4 primary outcomes in all. 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 21 Jun 2021.