Risk of Oxygen During Cardiac Surgery (ROCS) Trial

131128

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.

2016-04-05

2020-10-08

2021-01-08

Completed

Early phase I

213

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 213, 'type': 'ACTUAL'}}

2024-02-01