Off-Pump and On-Pump Techniques and Oxidative Stress in CABG Surgery (CABG)

September 24, 2021 updated by: Ökkeş Hakan Miniksar, Bozok University

Effect of Off-Pump and On-Pump Techniques on Oxidative Stress Biomarkers in CABG

CABG (coronary artery bypass graft) surgery is among the most common heart surgeries performed in the heart pump. In CABG surgery, operations performed on the beating heart without the use of CPB (off-pump) are frequently performed (30-60%) (1).

To the best of our knowledge, there has been no study examining cerebral oxygenation values, oxidative stress levels and postoperative results in CABG operations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CABG (coronary artery bypass graft) surgery is among the most common heart surgeries performed in the heart pump. In CABG surgery, operations performed on the beating heart without the use of CPB (off-pump) are frequently performed (30-60%) (1). Off-pump coronary artery bypass surgery is also called beating-heart surgery, and its purpose is to avoid cardiopulmonary bypass completely without the support of a heart lung machine, thereby avoiding its adverse effects (3-5). It has been reported that the off-pump CPB surgical method is associated with a decrease in the incidence of early stage and major complications compared to the traditional CPB method (2). Exposure to surgical stress leads to autonomic, visceral, and immunological responses, leading to oxidative stress, neurochemical and hormonal abnormalities (3).In addition to the non-physiological hemodynamic conditions that occur during CABG surgery, a significant increase is observed in inflammatory response and oxidative stress biomarkers due to surgical trauma, cardiopulmonary bypass (CPB) and organ reperfusion injury (4).For this reason, it is important to detect the presence and severity of postoperative adverse outcomes after CABG early. To the best of our knowledge, there has been no study examining cerebral oxygenation values, oxidative stress levels and postoperative results in CABG operations.

This prospective observational study is planned to include 64 adult patients aged 30-80 years who will undergo CABG surgery. Patients will be grouped according to the surgical technique (on-pump and off-pump) determined (indicated) according to the cardiovascular risk status of the patient by the Cardiovascular Surgery department.

Patients' perioperative cerebral hemoglobin oxygen saturations will be recorded with the Regional Oximeter (non-invasive cerebral oxygenation measurement device).

In patients undergoing On-Pump bypass, at the beginning of the CABG surgery (basal), during the aortic clamp, 15 minutes after the clamp is lifted, the remaining 3 ml of blood will be centrifuged at 3000 rpm for 5 minutes and the serum part will be separated.

In off-pump bypass surgery patients, 3 ml of blood will be centrifuged at the beginning of the operation, at the beating phase and 15 minutes after the beating process is completed.

Total antioxidant status, Total oxidant status, Superoxide dismutase, Malondialdehyde will be measured in the Enzyme-Linked ImmunoSorbent Assay device from blood samples taken from all patients in the study, and their concentrations will be determined.

Study Type

Observational

Enrollment (Actual)

64

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
      • Yozgat, Turkey
        • Bozok University Medical Center

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

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

It is planned to participate in this prospective observational study of 64 volunteer patients undergoing Coronary artery bypass grafting (CABG) surgery by the Department of Cardiovascular Surgery.

Description

Inclusion Criteria:

  • Undergo CABG surgery with on-pump and off-pump technique,
  • Volunteer to participate in the study,
  • 30-80 years old

Exclusion Criteria:

  • Those with chronic kidney failure
  • Those with liver failure
  • Under 30 and over 80

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
On-pump CABG
Patients with an on-pump indication by the cardiovascular surgery department will be included in the study.
Procedure: On-Pump CABG
Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.
Procedure: Off-Pump CABG
Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.
Off-pump CABG
Patients with an off-pump indication by the cardiovascular surgery department will be included in the study.
Procedure: On-Pump CABG
Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.
Procedure: Off-Pump CABG
Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative stress level
Time Frame: Intraoperative period
Oxidative stress biomarker levels between on-pump and off-pump coronary artery bypass groups
Intraoperative period
TAS
Time Frame: Intraoperative period
Total antioxidant status
Intraoperative period
TOS
Time Frame: Intraoperative period
Total oxidant status
Intraoperative period
SOD
Time Frame: Intraoperative period
Superoxide dismutase
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oximetry
Time Frame: Intraoperative period
Cerebral haemoglobin oxygen saturations (%)
Intraoperative period

Collaborators and Investigators

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

Sponsor

Bozok University

Investigators

  • Study Chair: Ökkeş Hakan Miniksar, Asist.Prof, Yozgat Bozok University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 24, 2021

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 189_2020.01.18_15

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

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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