NCT02361944已完成2 期
Risk of Oxygen During Cardiac Surgery (ROCS) Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Intraoperative Systemic Oxidative Damage
研究概览
简要总结
The investigators will recruit and randomize 200 elective cardiac surgery patients to receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test the hypothesis that intraoperative physiologic oxygenation decreases the generation of reactive oxygen species, oxidative damage, and postoperative organ injury compared to hyper-oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
排除标准
- •Current acute coronary syndrome (defined as ST elevation myocardial infarction or non-ST elevation myocardial infarction (troponin leak within 72 hours of surgery or consent +/- EKG changes consistent with myocardial ischemia)).
- •Home supplemental oxygen use.
- •Preoperative supplemental oxygen requirement to maintain arterial O2 sat of 92%.
- •Right to left intracardiac shunt including atrial septal defect and ventricular septal defect with Cor Pulmonale.
- •Carotid stenosis defined as >50% stenosis.
- •Cardiac surgery that requires intraoperative circulatory arrest, such as aortic arch replacement.
- •Current use of hemo- or peritoneal dialysis.
- •Pregnancy
研究组 & 干预措施
Normoxia
Experimental
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.
干预措施: Oxygen - normoxia (Drug)
Hyperoxia
Active Comparator
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.
干预措施: Oxygen - hyperoxia (Drug)
结局指标
主要结局
Intraoperative Systemic Oxidative Damage
时间窗: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)
quantified by measuring F2-isoprostanes isofurans following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting
Acute Kidney Injury
时间窗: baseline to postoperative day 2
quantified by change in serum creatinine concentration
次要结局
- Vascular Reactivity / Endothelial Function (as Measured by Flow Mediated Dilation)(ICU admission (immediately after arrival in ICU from operating room))
- Mitochondrial Function(up to 2 days following surgery)
- Number of People With Arrhythmia(from surgery to hospital discharge, average of 6 days following surgery)
- Myocardial Injury or Infarction(morning of postoperative day 1)
- Number of People With Stroke(from surgery to hospital discharge, average of 6 days following surgery)
- Postoperative Cognitive Dysfunction(up to 18 months following surgery)
- Reactive Oxygen Species Production(end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Acute Kidney Injury Estimated by Urine Concentration of NGAL(baseline to 2 days following surgery)
- Oxygenation and Perfusion (Cerebral Oximetry)(continuously assessed throughout surgery and recorded each minute)
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, EC50)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Oxygenation and Perfusion (SpO2)(during surgery)
- Oxygenation and Perfusion (PaO2)(end of surgery, defined as separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Vascular Reactivity / Endothelial Function (Peripheral Artery Tonometry)(ICU admission (immediately after arrival in ICU from operating room))
- Respiratory Failure(from surgery to hospital discharge, average of 6 days following surgery)
- Inflammation(up to 2 days following surgery)
- Oxygenation and Perfusion (Lactate)(ICU admission (immediately after arrival in ICU from operating room))
- Acute Kidney Injury, According to KDIGO Criteria(up to 7 days following surgery)
- Acute Kidney Injury Estimated by Urine Concentration of TIMP-2 IGFBP7(baseline to 2 days following surgery)
- Oxygenation and Perfusion (SvO2)(end of surgery, defined as following separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Dependent Vasodilation, Emax)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, Emax)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Chronic Kidney Disease(12 months following surgery)
- Acute Brain Dysfunction (Delirium)(from surgery to hospital discharge, average of 6 days following surgery)
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, Endothelial Independent Vasodilation, EC50)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, EC50)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Hemolysis(separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Oxygenation and Perfusion (Cardiac Index)(end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Vascular Reactivity / Endothelial Function (Tension Wire Myography, sGC Activation Vasodilation, Emax)(tissue collected during surgery when heart is exposed approximately 2 hours into intervention)
- Vascular Reactivity / Endothelial Function (PAI-1)(end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
- Vascular Reactivity / Endothelial Function (E-selectin)(end of surgery, defined as immediately after separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention))
研究者
Frederic T Billings IV
Assistant Professor of Anesthesiology
Vanderbilt University
研究点 (1)
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