NCT04741555

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

February 2, 2021

Last Update Submit

June 18, 2021

Conditions

Keywords

neutrophil / lymphocyte ratiosuric acid levelmortalitycoronary bypass surgeryPostoperative Complications

Outcome Measures

Primary Outcomes (4)

  • neutrophil / lymphocyte ratios

    The effect on postoperative complications of preoperative neutrophil lymphocyte ratio in open heart surgery

    postoperative 2 week

  • neutrophil / lymphocyte ratios

    The effect on mortality of preoperative neutrophil lymphocyte ratio in open heart surgery

    postoperative 1 year

  • uric acid values

    The effect on mortality of preoperative uric acid values in open heart surgery

    postoperative 1 year

  • uric acid values

    The effect on postoperative complications of preoperative uric acid values in open heart surgery

    postoperative 2 week

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Elective patients undergoing open heart surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

June 1, 2020

Primary Completion

February 15, 2021

Study Completion

June 1, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations