Abstract
BackgroundAnesthesiologists administer excess supplemental oxygen (hyper-oxygenation) to patients during surgery to avoid hypoxia. Hyper-oxygenation, however, may increase the generation of reactive oxygen species and cause oxidative damage. In cardiac surgery, increased oxidative damage has been associated with postoperative kidney and brain injury. We hypothesize that maintenance of normoxia during cardiac surgery (physiologic oxygenation) decreases kidney injury and oxidative damage compared to hyper-oxygenation.Methods/designThe Risk of Oxygen during Cardiac Surgery (ROCS) trial will randomly assign 200 cardiac surgery patients to receive physiologic oxygenation, defined as the lowest fraction of inspired oxygen (FIO2) necessary to maintain an arterial hemoglobin saturation of 95 to 97%, or hyper-oxygenation (FIO2 = 1.0) during surgery. The primary clinical endpoint is serum creatinine change from baseline to postoperative day 2, and the primary mechanism endpoint is change in plasma concentrations of F2-isoprostanes and isofurans. Secondary endpoints include superoxide production, clinical delirium, myocardial injury, and length of stay. An endothelial function substudy will examine the effects of oxygen treatment and oxidative stress on endothelial function, measured using flow mediated dilation, peripheral arterial tonometry, and wire tension myography of epicardial fat arterioles.DiscussionThe ROCS trial will test the hypothesis that intraoperative physiologic oxygenation decreases oxidative damage and organ injury compared to hyper-oxygenation in patients undergoing cardiac surgery.Trial registrationClinicalTrials.gov, ID: NCT02361944. Registered on the 30th of January 2015.
Highlights
Anesthesiologists administer excess supplemental oxygen to patients during surgery to avoid hypoxia
The Risk of Oxygen during Cardiac Surgery (ROCS) trial will test the hypothesis that intraoperative physiologic oxygenation decreases oxidative damage and organ injury compared to hyper-oxygenation in patients undergoing cardiac surgery
We recently demonstrated that intraoperative oxidative damage, quantified by measuring plasma concentrations of F2- isoprostanes, independently predicts acute kidney injury (AKI) following cardiac surgery [2]
Summary
Hyper-oxygenation during cardiac surgery is a common practice, but hyper-oxygenation might increase organ injury by increasing the production of ROS and increasing oxidative damage. The ROCS trial will test the hypothesis that physiologic oxygenation during surgery will decrease the production of ROS, oxidative damage, and organ injury compared to hyper-oxygenation. Dissimilar from prior studies, the ROCS trial will randomize cardiac surgery patients to physiologic oxygenation or hyper-oxygenation throughout the entire operative period and will measure the putative mechanisms involved, namely oxidative stress and endothelial function, in addition to clinical outcomes. The ROCS trial will provide insights into mechanisms of perioperative oxidative stress and organ injury and potentially demonstrate that maintenance of physiologic oxygenation during surgery improves the care of cardiac surgery patients compared to the hyperoxygenation that patients typically receive.
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