Risk of Oxygen During Cardiac Surgery Trial (ROCS)

Vanderbilt University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cardiac Surgery

Treatments

Drug: Oxygen - hyperoxia

Drug: Oxygen - normoxia

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02361944

131128

R01GM112871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

213 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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