Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
研究概览
简要总结
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA II-III
- •Patients with EF higher than 50%.
- •patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)
排除标准
- •patients with Diabetes Mellitus
- •patients with COPD
- •Patients with Cerebral Vascular Disease
- •Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)
结局指标
主要结局
change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
时间窗: 72 hours
As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated
次要结局
- Partial pressure of oxygen(mmHg),(72 hours)
- Oxygen saturation (%)(72 hours)
- Partial pressure of carbondioxide(mm Hg)(72 hours)
- lactate (mmol/l)(72 hours)
- systolic arterial pressure (mmHg),(72 hours)
- diastolic arterial pressure (mmHg)(72 hours)
- ph values(72 hours)
- heart rate (beat/min)(72 hours)
研究者
Guniz M.Koksal
Professor Anesthesiologist
Istanbul University