Cardiopulmonary bypass (CPB) triggers marked cytokine release often followed by a systemic inflammatory response syndrome, associated with adverse postoperative outcomes. This trial investigates the intraoperative use of haemoadsorption (HA) during cardiac surgery with CPB to assess its impact on postoperative systemic inflammatory response. In this prospective randomised controlled trial (ethics approval no. 5094-14DRKS00007928), patients (> 65 years) undergoing elective on-pump cardiac surgery were randomised to intraoperative HA (CytoSorb) during CPB or standard care without HA. Primary outcome was the difference in mean interleukin (IL)-6 serum concentrations between groups on intensive care unit (ICU) admission. The secondary outcomes included various clinical and biochemical endpoints. Statistical methods included paired and unpaired t-tests, Wilcoxon, Mann–Whitney U-tests, and chi-square tests. Thirty-eight patients were allocated to receive either intraoperative HA (n = 19) or standard care (n = 19). The primary outcome, IL-6 levels on ICU admission, did not differ between the study group and controls (214.4 ± 328.8 vs. 155.8 ± 159.6 pg/ml, p = 0.511). During surgery pre- versus post-adsorber IL-2, IL-6, IL-8, IL-10, heparan sulfate and myoglobin post- levels were reduced. Furthermore, IL-6 levels did not differ between the study groups on day 1 and 2 in the ICU. While sequential organ failure assessment scores, lactate levels, and C-reactive protein and procalcitonin (PCT) showed no statistically significant differences. Regarding haemodynamic stability in the treatment group the cardiac index (3.2 ± 0.7 vs. 2.47 ± 0.47 l/min/m2, p = 0.012) on ICU day 2 increased, and lower fluid requirements as well as decreased fibrinogen requirement were observed. Need for renal replacement therapy did not differ though a shorter duration was observed in the treatment group. Time on ventilator, respiratory parameters, infectious complications, delirium scores, ICU and hospital lengths of stay, and mortality did not differ between groups. HA did not reduce the IL-6 level on ICU admission or afterwards. Even though HA reduced cytokine load during cardiac surgery in the treatment group. There were no significant differences between groups in the postoperative course of other cytokine concentrations, organ dysfunction, ICU and hospital lengths of stay and mortality rates. Trial registration prospectively DRKS00007928 and published under: Baumann A, Buchwald D, Annecke T, Hellmich M, Zahn PK, Hohn A. RECCAS - REmoval of Cytokines during Cardiac Surgery: study protocol for a randomised controlled trial. Trials. 2016;17: 137.

中文翻译：

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CArdiac 手术期间去除细胞因子 （RECCAS）：一项随机对照试验


体外循环 （CPB） 触发显着的细胞因子释放，通常随后是全身炎症反应综合征，与不良术后结果相关。本试验调查了 CPB 心脏手术期间术中血液吸附 （HA） 的使用，以评估其对术后全身炎症反应的影响。在这项前瞻性随机对照试验（伦理批准号 5094-14DRKS00007928）中，接受择期体外循环心脏手术的患者（> 65 岁）在 CPB 期间被随机分配到术中 HA （CytoSorb） 或无 HA 的标准护理组。主要结局是重症监护病房 （ICU） 入住组间平均白细胞介素 （IL）-6 血清浓度的差异。次要结局包括各种临床和生化终点。统计方法包括配对和非配对 t 检验、Wilcoxon、Mann-Whitney U 检验和卡方检验。38 例患者被分配接受术中 HA （n = 19） 或标准护理 （n = 19）。主要结局，即入住 ICU 的 IL-6 水平，在研究组和对照组之间没有差异 （214.4 ± 328.8 vs. 155.8 ± 159.6 pg/ml，p = 0.511）。在吸附剂前后的手术期间，IL-2、IL-6、IL-8、IL-10、硫酸乙酰肝素和肌红蛋白后水平降低。此外，在 ICU 第 1 天和第 2 天，研究组之间的 IL-6 水平没有差异。而序贯器官衰竭评估评分、乳酸水平以及 C 反应蛋白和降钙素原 （PCT） 显示差异无统计学意义。关于治疗组的血流动力学稳定性，ICU 第 2 天的心脏指数 （3.2 ± 0.7 vs. 2.47 ± 0.47 l/min/m2，p = 0.012） 增加，观察到液体需求降低，纤维蛋白原需求降低。 对肾脏替代治疗的需求没有差异，尽管在治疗组中观察到持续时间较短。呼吸机使用时间、呼吸参数、感染并发症、谵妄评分、ICU 和住院时间以及死亡率在组间没有差异。医管局在入住 ICU 时或之后没有降低 IL-6 水平。尽管 HA 降低了治疗组心脏手术期间的细胞因子负荷。组间其他细胞因子浓度、器官功能障碍、ICU 和住院时间和死亡率的术后病程差异无统计学意义。试验注册前瞻性DRKS00007928并发表于： Baumann A， Buchwald D， Annecke T， Hellmich M， Zahn PK， Hohn A. RECCAS - 心脏手术期间细胞因子的去除：随机对照试验的研究方案。试验。2016;17: 137.