The Effect of Arterial Oxygen Parameters on Antioxidant Parameters

November 7, 2020 updated by: Umran Karaca, Bursa Yüksek İhtisas Education and Research Hospital

The Effect of Arterial Oxygen Levels on Thiol Disulfide Homeostasis and Ischemia Modified Albumin in Coronary Artery Bypass Surgery

We aimed to measure the changes in your blood values caused by different but safe oxygen values used by us during your heart surgery under laboratory conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hyperoxia is often preferred due to the risk of tissue hypoxia that may develop in cardiac surgery. It is thought that with hyperoxemia, ischemia reperfusion damage increases, microcirculation is impaired and tissue oxygenation is impaired.Oxidative damage occurs in cases of increased oxidative stress and impaired antioxidant balance.It was aimed to investigate oxidative damage by recording modified albumin and thiol disulfide in blood simultaneously by recording arterial oxygen levels at determined times during cardiac surgery.

Study Type

Observational

Enrollment (Actual)

100

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
      • Bursa, Turkey, 60160
        • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

128 patients scheduled for cardiac surgery

Description

Inclusion Criteria:

  • patient scheduled for cardiac surgery
  • ASA>3
  • Aged 18-75 years

Exclusion Criteria:

  • those with valvular disease
  • EF<%40
  • BMI>40 kg/m2
  • presence of arrhythmia that impairs hemodynamics
  • previous history of cerebrovascular
  • diagnosed with end-stage organ failure

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Group 1: Pressure of arterial oxygen> 200 mmHg during the coronary surgery
Diagnostic test: taken venous sample
Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.
group 2
Group 2: Pressure of arterial oxygen<200 mmHg and >80 mmHg during the coronary surgery
Diagnostic test: taken venous sample
Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of oxidative damage
Time Frame: 48 hours after operation
To measure the degree of oxidative damage in the patient's blood at different oxygen values used in cardiac bypass surgeries with thiol disulfide homeostasis and ischemia-modified albumin at times determined.
48 hours after operation

Collaborators and Investigators

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

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Study Director: Tuğba O Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Şeyda Ö Özgünay, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Filiz A Ata, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Canan Y Yılmaz, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Şermin E Eminoğlu, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Halil Erkan S Sayan, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Yasemin Ü Üstündağ, MD, Bursa Yüksek İhtisas Education and Research Hospital
  • Study Director: Anıl O Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital

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)

January 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 7, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bursa High Education Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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