Effects of Two Intraoperative Arterial Oxygen Targets on Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin in Coronary Artery Bypass Graft Surgery
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
- 2
- 主要终点
- Native Thiol Concentration
研究概览
简要总结
This single-center randomized trial compared two intraoperative arterial oxygen tension (PaO2) target strategies in adults undergoing elective isolated coronary artery bypass graft surgery. Sixty-four participants were assigned 1:1 to a higher target (PaO2 200 mmHg or greater) or a lower target (PaO2 80 to less than 200 mmHg). The study evaluated perioperative changes in thiol-disulfide homeostasis and ischemia-modified albumin.
详细描述
Hyperoxemia is frequently used during cardiac surgery to reduce the risk of hypoxemia, but excessive oxygen exposure may increase oxidative stress and ischemia-reperfusion injury. In this prospective, randomized, parallel-group study, inspired oxygen concentration was adjusted intraoperatively to achieve the assigned PaO2 target. Allocation was generated by computer and concealed with sealed envelopes. The clinical team was aware of group assignment because oxygen administration had to be titrated, whereas laboratory personnel were blinded. Biomarker samples were collected before anesthesia induction, 30 minutes after aortic cross-clamp removal, at the end of surgery, and 6 hours postoperatively. Sixty-four participants were randomized (32 per group), and 59 participants were included in the final analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory personnel who measured thiol-disulfide homeostasis and ischemia-modified albumin were blinded to group assignment. The anesthesia team was not blinded because it adjusted the inspired oxygen fraction to achieve the assigned PaO2 target.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Scheduled for elective isolated coronary artery bypass graft surgery
- •American Society of Anesthesiologists physical status III or higher
- •Left ventricular ejection fraction of 40% or greater
排除标准
- •Valvular heart disease requiring concomitant valve surgery
- •Left ventricular ejection fraction below 40%
- •Hemodynamically significant arrhythmia
- •Previous stroke or transient ischemic attack
- •End-stage organ failure
研究组 & 干预措施
Higher PaO2 Target (200 mmHg or Greater)
During anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) at 200 mmHg or greater. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%.
干预措施: Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater (Other)
Lower PaO2 Target (80 to Less Than 200 mmHg)
During anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) from 80 to less than 200 mmHg. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%.
干预措施: Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg (Other)
结局指标
主要结局
Native Thiol Concentration
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum native thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Total Thiol Concentration
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum total thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Disulfide Concentration
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum disulfide concentration calculated as one half of the difference between total thiol and native thiol concentrations and reported in micromoles per liter (micromol/L).
Disulfide-to-Native Thiol Ratio
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum disulfide concentration to native thiol concentration, calculated and reported as a percentage.
Disulfide-to-Total Thiol Ratio
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum disulfide concentration to total thiol concentration, calculated and reported as a percentage.
Native Thiol-to-Total Thiol Ratio
时间窗: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum native thiol concentration to total thiol concentration, calculated and reported as a percentage.
assessment of oxidative damage
时间窗: 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.
次要结局
- Ischemia-Modified Albumin Level(Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively)
研究者
Umran Karaca
Medical Doctor
Bursa Yuksek Ihtisas Training and Research Hospital