一项关于体外循环期间避免高氧血症的多中心、随机、对照IIb期试验。
A Multicenter, Randomized, Controlled Phase IIb Trial of Avoidance of Hyperoxemia during Cardiopulmonary Bypass.
作者信息
McGuinness Shay P, Parke Rachael L, Drummond Kate, Willcox Tim, Bailey Michael, Kruger Cornelius, Baker Megan, Cowdrey Keri-Anne, Gilder Eileen, McCarthy Lianne, Painter Thomas
机构信息
From the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand (S.P.M., R.L.P.); Medical Research Institute of New Zealand, Wellington, New Zealand (S.P.M., R.L.P.); ANZIC-Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia (S.P.M., R.L.P., M.B.); Royal Adelaide Hospital, Adelaide, South Australia (K.D.); Clinical Perfusion, Green Lane Cardiothoracic Surgical Unit, Auckland City Hospital, Auckland, New Zealand (T.W.); and Department of Anaesthesiology, University of Auckland, Auckland, New Zealand (T.W.)Auckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandAuckland City Hospital, Auckland, New ZealandCalvary Wakefield Hospital, Adelaide, South Australia.
出版信息
Anesthesiology. 2016 Sep;125(3):465-73. doi: 10.1097/ALN.0000000000001226.
BACKGROUND
Cardiac surgery utilizing cardiopulmonary bypass (CPB) is one of the most common forms of major surgery. Cardiac surgery-associated multiorgan dysfunction (CSA-MOD) is well recognized and includes acute kidney injury (AKI), hepatic impairment, myocardial damage, and postoperative neurologic deficit. Pathophysiology of CSA-MOD involves numerous injurious pathways linked to the use of CPB including oxidative stress and formation of reactive iron species. During cardiac surgery with CPB, arterial return blood is oxygenated to supranormal levels. This study aimed to determine whether the avoidance of arterial hyperoxemia decreased oxidative stress and reduced the severity of the multiorgan dysfunction in patients undergoing cardiac surgery utilizing CPB.
METHODS
The study was a multicenter, open-label, parallel-group, randomized controlled study of the avoidance of arterial hyperoxemia versus usual care in patients undergoing cardiac surgery involving CPB. Primary outcome was the incidence and severity of AKI. Secondary outcomes included serum biomarkers for CSA-MOD, duration of mechanical ventilation, and length of intensive care and hospital stay.
RESULTS
A total of 298 patients were randomized and analyzed at two hospitals in New Zealand and Australia. Mean PaO2 was significantly different between groups during CPB. There was no difference in the development of AKI (intervention arm 72.0% vs. usual care 66.2%; difference, -5.8% [95% CI, -16.1 to 4.7%]; P = 0.28), other markers of organ damage, or intensive care unit and hospital length of stay.
CONCLUSIONS
Avoiding modest hyperoxemia during CPB failed to demonstrate any difference in AKI, markers of organ damage, or length of stay.
背景
利用体外循环（CPB）的心脏手术是最常见的大手术形式之一。心脏手术相关的多器官功能障碍（CSA-MOD）已得到充分认识，包括急性肾损伤（AKI）、肝功能损害、心肌损伤和术后神经功能缺损。CSA-MOD的病理生理学涉及许多与CPB使用相关的损伤途径，包括氧化应激和活性铁物种的形成。在CPB心脏手术期间，动脉回血被氧合至超常水平。本研究旨在确定避免动脉血氧过高是否能降低氧化应激，并减轻接受CPB心脏手术患者的多器官功能障碍的严重程度。
方法
本研究是一项多中心、开放标签、平行组、随机对照研究，比较接受涉及CPB的心脏手术患者避免动脉血氧过高与常规治疗的效果。主要结局是AKI的发生率和严重程度。次要结局包括CSA-MOD的血清生物标志物、机械通气时间、重症监护时间和住院时间。
结果
共有298例患者在新西兰和澳大利亚的两家医院进行了随机分组和分析。CPB期间两组的平均动脉血氧分压（PaO2）有显著差异。AKI的发生率（干预组72.0% vs.常规治疗组66.2%；差异为-5.8% [95% CI，-16.1%至4.7%]；P = 0.28）、其他器官损伤标志物或重症监护病房和住院时间方面无差异。
结论
在CPB期间避免适度的血氧过高未能显示出在AKI、器官损伤标志物或住院时间方面有任何差异。
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