Hohn Andreas, Malewicz-Oeck Nathalie M, Buchwald Dirk, Annecke Thorsten, Zahn Peter K, Baumann Andreas
Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
Department of Anesthesiology and Intensive Care Medicine, Cologne University Hospital, Kerpener Str. 62, 50937, Cologne, Germany.
Crit Care. 2024 Dec 12;28(1):406. doi: 10.1186/s13054-024-05175-9.
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/m, 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.
2016;17: 137.
体外循环（CPB）会引发显著的细胞因子释放，常随后出现全身炎症反应综合征，与术后不良结局相关。本试验旨在研究在CPB心脏手术中术中使用血液吸附（HA），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（年龄>65岁）被随机分为CPB期间术中使用HA（CytoSorb）组或不使用HA的标准治疗组。主要结局是重症监护病房（ICU）入院时两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检验、Mann - Whitney U检验和卡方检验。
38例患者被分配接受术中HA（n = 19）或标准治疗（n = 19）。主要结局，即ICU入院时的IL - 6水平，研究组与对照组之间无差异（214.4±328.8 vs. 155.8±159.6 pg/ml，p = 0.511）。在手术期间，吸附器前后IL - 2、IL - 6、IL - 8、IL - 10、硫酸乙酰肝素和肌红蛋白的水平在吸附后降低。此外，ICU第1天和第2天研究组之间的IL - 6水平无差异。而序贯器官衰竭评估评分、乳酸水平、C反应蛋白和降钙素原（PCT）无统计学显著差异。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/m，p = 0.012）升高，且观察到液体需求量降低以及纤维蛋白原需求量减少。肾脏替代治疗的需求无差异，尽管治疗组的持续时间较短。两组之间呼吸机使用时间、呼吸参数、感染并发症、谵妄评分、ICU和住院时间以及死亡率无差异。
HA并未降低ICU入院时或之后的IL - 6水平。尽管HA在治疗组心脏手术期间降低了细胞因子负荷。两组在术后其他细胞因子浓度变化过程、器官功能障碍、ICU和住院时间以及死亡率方面无显著差异。试验前瞻性注册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清除：一项随机对照试验的研究方案。
2016；17：137。
