体外循环期间的高氧并不减少心脏手术后的心血管并发症：CARDIOX 随机临床试验。
Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial.
机构信息
Department of Anesthesiology and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du Professeur Christian Cabrol, 80054, Amiens, France.
MP3CV, EA7517, CURS, Jules Verne University of Picardy, 80054, Amiens, France.
出版信息
Intensive Care Med. 2019 Oct;45(10):1413-1421. doi: 10.1007/s00134-019-05761-4. Epub 2019 Oct 1.
PURPOSE
Data on the benefit or or harmful effects of oxygen level on ischemic reperfusion injuries in cardiac surgery are insufficient. We hypothesized that hyperoxia during cardiopulmonary bypass decreases the incidence of postoperative atrial fibrillation (POAF) and ventricular fibrillation, and therefore decreases cardiovascular morbidity (CARDIOX study).
METHODS
An open-label, randomized clinical trial including adults undergoing elective cardiac surgery, i.e. cardiopulmonary bypass (CPB) randomized 1:1 to an intervention group or standard group at two French University Hospitals from June 2016 to October 2018. The intervention consisted in delivering of an inspired fraction of oxygen of one to one during CPB. The standard care consisted in delivering oxygen to achieve a partial arterial blood pressure less than 150 mmHg. The primary endpoint was the occurrence of POAF and/or ventricular tachycardia/ventricular fibrillation (VT/VF) within the 15 days following cardiac surgery. The secondary endpoint was the occurrence of major adverse cardiovascular events (MACCE: in-hospital mortality, stroke, cardiac arrest, acute kidney injury, and mesenteric ischemia).
RESULTS
330 patients were randomly assigned to either the intervention group (n = 161) or the standard group (n = 163). Mean PaO was 447 ± 98 mmHg and 161 ± 60 mmHg during CPB, for the intervention and standard group (p < 0.0001) respectively. The incidence of POAF or VT/VF were similar in the intervention group and the standard group (30% [49 of 161 patients] and 30% [49 of 163 patients], absolute risk reduction 0.4%; 95% CI, - 9.6-10.4; p = 0.94). MACCE was similar between groups with, an occurrence of 24% and 21% for the intervention group and the standard groups (absolute risk reduction 3.4%; 95% CI, - 5.7-12.5; p = 0.47) respectively. After adjustment, the primary and secondary endpoints remained similar for both groups.
CONCLUSION
Hyperoxia did not decrease POAF and cardiovascular morbidity following cardiac surgery with CPB. CLINICALTRIAL.
GOV IDENTIFIER
NCT02819739.
目的
关于体外循环期间氧水平对缺血再灌注损伤有益或有害影响的数据不足。我们假设体外循环期间的高氧血症可降低术后心房颤动（POAF）和心室颤动的发生率，从而降低心血管发病率（CARDIOX 研究）。
方法
一项开放标签、随机临床试验，纳入 2016 年 6 月至 2018 年 10 月在法国两所大学医院接受择期心脏手术的成年人，即体外循环（CPB）患者 1:1 随机分为干预组或标准组。干预措施包括在 CPB 期间输送 1:1 的吸入氧分数。标准护理包括输送氧气以实现低于 150mmHg 的部分动脉血压。主要终点是心脏手术后 15 天内发生 POAF 和/或室性心动过速/心室颤动（VT/VF）。次要终点是主要不良心血管事件（MACCE：院内死亡率、中风、心脏骤停、急性肾损伤和肠系膜缺血）的发生。
结果
330 例患者随机分为干预组（n=161）或标准组（n=163）。CPB 期间，平均 PaO 分别为 447±98mmHg 和 161±60mmHg，干预组和标准组（p<0.0001）。干预组和标准组 POAF 或 VT/VF 的发生率相似（30%[161 例患者中的 49 例]和 30%[163 例患者中的 49 例]，绝对风险降低 0.4%；95%CI，-9.6-10.4；p=0.94）。两组 MACCE 相似，干预组和标准组的发生率分别为 24%和 21%（绝对风险降低 3.4%；95%CI，-5.7-12.5；p=0.47）。调整后，两组的主要和次要终点仍相似。
结论
CPB 心脏手术后高氧血症并未降低 POAF 和心血管发病率。临床试验。
注册号
NCT02819739.
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