The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial
The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial
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DOI：
10.1186/s13063-017-2021-5
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发表时间：
2017-06-26
期刊：
影响因子：
2.5
通讯作者：
Billings, Frederic T.
中科院分区：
文献类型：
--
作者：
Lopez, Marcos G.;Pretorius, Mias;Billings, Frederic T.
背景：麻醉师在手术过程中给患者过量补充氧（过度氧合）以避免缺氧。然而，过度氧合可能增加活性氧的产生并引起氧化损伤。在心脏手术中，氧化损伤增加与术后肾和脑损伤有关。我们假设在心脏手术中维持常氧（生理性氧合）与过度氧合相比减少肾损伤和氧化损伤。心脏手术期间的氧气风险（ROCS）试验将随机分配200名心脏手术患者接受生理氧合，定义为维持95 - 97%的动脉血红蛋白饱和度所需的最低吸入氧分数（FIO 2），或术中氧合过度（FIO 2 = 1.0）。主要临床终点是从基线到术后第2天的血清肌酐变化，主要机制终点是F-2-异前列烷和异呋喃的血浆浓度变化。次要终点包括超氧化物生成、临床谵妄、心肌损伤和住院时间。内皮功能亚组研究将探讨氧治疗和氧化应激对内皮功能的影响，测量使用流量介导的扩张，外周动脉张力，和钢丝张力myography的心外膜脂肪arterioles.Discussion：ROCS试验将测试的假设，即术中生理氧合减少氧化损伤和器官损伤相比，在接受心脏手术的患者氧合过度。
Background: Anesthesiologists 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/design: The 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 F-2-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.Discussion: The 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.