NCT02361944CompletedPhase 2
Risk of Oxygen During Cardiac Surgery (ROCS) Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- Intraoperative Systemic Oxidative Damage
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.
Exclusion Criteria
- •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
Arms & Interventions
Normoxia
Experimental
Oxygen administration to maintain a hemoglobin oxygen saturation of 95-97% or arterial PaO2 80-110 mmHg during surgery.
Intervention: Oxygen - normoxia (Drug)
Hyperoxia
Active Comparator
Fraction of inspired oxygen 1.0 during mechanical ventilation and 0.8 during cardiopulmonary bypass during surgery.
Intervention: Oxygen - hyperoxia (Drug)
Outcomes
Primary Outcomes
Intraoperative Systemic Oxidative Damage
Time Frame: 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
Time Frame: baseline to postoperative day 2
quantified by change in serum creatinine concentration
Secondary Outcomes
- 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))
Investigators
Frederic T Billings IV
Assistant Professor of Anesthesiology
Vanderbilt University
Study Sites (1)
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