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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cardiac Surgery trials