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CompletedNCT04834219CABGUpdated Sep 28, 2021

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

An observational study in Cerebral Oxygenation, Oxidative Stress and Myocardial Infarction, sponsored by Bozok University. Completed at 1 site in Turkey. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Bozok University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
64
Ages
30 Years to 80 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Cerebral Oxygenation
  • Oxidative Stress
  • Myocardial Infarction

Keywords

  • Coronary artery bypass surgery
  • Oxidative stress
  • Cerebral oxygenation
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 64 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Bozok University is the lead sponsor of 53 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those with chronic kidney failure
  • Those with liver failure
  • Under 30 and over 80
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
64 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • On-pump CABG

    Patients with an on-pump indication by the cardiovascular surgery department will be included in the study.

    Procedure: On-Pump CABG · Procedure: Off-Pump CABG

  • Off-pump CABG

    Patients with an off-pump indication by the cardiovascular surgery department will be included in the study.

    Procedure: On-Pump CABG · Procedure: Off-Pump CABG

Interventions

  • ProcedureOn-Pump CABG

    Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.

  • ProcedureOff-Pump CABG

    Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.

06

What researchers measure

Primary outcomes

  1. Oxidative stress level

    Oxidative stress biomarker levels between on-pump and off-pump coronary artery bypass groups

    Time frame: Intraoperative period

  2. TAS

    Total antioxidant status

    Time frame: Intraoperative period

  3. TOS

    Total oxidant status

    Time frame: Intraoperative period

  4. SOD

    Superoxide dismutase

    Time frame: Intraoperative period

Secondary outcomes

  1. Cerebral oximetry

    Cerebral haemoglobin oxygen saturations (%)

    Time frame: Intraoperative period

07

Study locations

1 site
  • Bozok University Medical Center
    Yozgat, Turkey
08

References and documents

Publications

  • Hussain G, Azam H, Baig MA, Ahmad N. Early outcomes of on-pump versus off-pump coronary artery bypass grafting. Pak J Med Sci. 2016 Jul-Aug;32(4):917-21. doi: 10.12669/pjms.324.9680. PubMed 27648039 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04834219
Lead sponsor
Bozok University
Responsible party
Ökkeş Hakan Miniksar (Assistant Professor, Bozok University) — Principal investigator
First posted
Apr 8, 2021
Start date
Jan 15, 2021
Primary completion
Sep 15, 2021
Completion
Sep 24, 2021
Last update
Sep 28, 2021

Study contacts

Ökkeş Hakan Miniksar, Asist.Prof
study chair · YOZGAT BOZOK UNIVERSITY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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