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

Completed

• Conditions: Cerebral Oxygenation; Oxidative Stress; Myocardial Infarction
• Interventions: Procedure: On-Pump CABG; Procedure: Off-Pump CABG

• Registration Number: NCT04834219
• Lead Sponsor: Bozok University

Brief 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.

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 Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Status Verified: 2021-09
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-24
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
On-pump CABG	Off-Pump CABG	Patients with an on-pump indication by the cardiovascular surgery department will be included in the study.
Off-pump CABG	Off-Pump CABG	Patients with an off-pump indication by the cardiovascular surgery department will be included in the study.
Off-pump CABG	On-Pump CABG	Patients with an off-pump indication by the cardiovascular surgery department will be included in the study.
On-pump CABG	On-Pump CABG	Patients with an on-pump indication by the cardiovascular surgery department will be included in the study.

Primary Outcome Measures

Name	Time	Method
TAS	Intraoperative period	Total antioxidant status
SOD	Intraoperative period	Superoxide dismutase
TOS	Intraoperative period	Total oxidant status
Oxidative stress level	Intraoperative period	Oxidative stress biomarker levels between on-pump and off-pump coronary artery bypass groups

Secondary Outcome Measures

Name	Time	Method
Cerebral oximetry	Intraoperative period	Cerebral haemoglobin oxygen saturations (%)

Trial Locations

Locations (1)

Bozok University Medical Center; 🇹🇷 Yozgat, Turkey