跳至主要内容
临床试验/NCT04834219
NCT04834219已完成不适用

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

Bozok University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
TAS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

TAS

时间窗: Intraoperative period

Total antioxidant status

SOD

时间窗: Intraoperative period

Superoxide dismutase

TOS

时间窗: Intraoperative period

Total oxidant status

Oxidative stress level

时间窗: Intraoperative period

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

次要结局

  • Cerebral oximetry(Intraoperative period)

研究者

发起方
Bozok University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ökkeş Hakan Miniksar

Assistant Professor

Bozok University

研究点 (1)

Loading locations...

相似试验