CompletedPhase 2/3

Risk of Oxygen During Cardiac Surgery Trial

United States213 participantsStarted 2016-04-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Intraoperative Systemic Oxidative Damage

Timeframe: separation from cardiopulmonary bypass or completion of off-pump coronary artery bypass grafting (approximately 3-5 hours into surgery and intervention)

Acute Kidney Injury

Timeframe: baseline to postoperative day 2

Trial details

NCT IDNCT02361944

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-08

Results submitted2023-07-19