Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Division of Haematology and Central Haematology Laboratory, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Crit Care. 2019 Apr 3;23(1):108. doi: 10.1186/s13054-019-2399-4.
Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb® (Cytosorbents, NJ, USA) is a recent device designed to remove cytokine from the blood using haemoadsorption (HA). This trial aims to evaluate the potential of CytoSorb® to decrease peri-operative cytokine levels in cardiac surgery.
We have conducted a single-centre pilot randomized controlled trial in 30 patients undergoing elective cardiac surgery and deemed at risk of complications. Patients were randomly allocated to either standard of care (n = 15) or CytoSorb® HA (n = 15) during cardiopulmonary bypass (CPB). Our primary outcome was the difference between the two groups in cytokines levels (IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-10, TNF-α, IFN-γ, MCP-1) measured at anaesthesia induction, at the end of CPB, as well as 6 and 24 h post-CPB initiation. In a consecutive subgroup of patients (10 in HA group, 11 in control group), we performed cross-adsorber as well as serial measurements of coagulation factors' activity (antithrombin, von Willebrand factor, factor II, V, VIII, IX, XI, and XII).
Both groups were similar in terms of baseline and peri-operative characteristics. CytoSorb® HA during CPB was not associated with an increased incidence of adverse event. The procedure did not result in significant coagulation factors' adsorption but only some signs of coagulation activation. However, the intervention was associated neither with a decrease in pro- or anti-inflammatory cytokine levels nor with any improvement in relevant clinical outcomes.
CytoSorb® HA during CPB was not associated with a decrease in pro- or anti-inflammatory cytokines nor with an improvement in relevant clinical outcomes. The procedure was feasible and safe. Further studies should evaluate the efficacy of CytoSorb® HA in other clinical contexts.
ClinicalTrials.gov NCT02775123 . Registered 17 May 2016.
体外循环（CPB）常伴有各种细胞因子介导的复杂炎症反应。在严重情况下，这种反应可能导致全身低血压和器官功能障碍。因此，细胞因子清除可能会改善心脏手术患者的预后。Cytosorb®（Cytosorbents，新泽西州，美国）是一种最近开发的设备，用于使用血液吸附（HA）从血液中去除细胞因子。本试验旨在评估 Cytosorb®降低心脏手术围手术期细胞因子水平的潜力。
我们在 30 名接受择期心脏手术且有并发症风险的患者中进行了一项单中心前瞻性随机对照试验。患者在体外循环（CPB）期间随机分配至标准治疗组（n=15）或 Cytosorb®HA 组（n=15）。我们的主要结局是两组在麻醉诱导时、CPB 结束时以及 CPB 开始后 6 和 24 小时测量的细胞因子水平（IL-1a、IL-1b、IL-2、IL-4、IL-5、IL-6、IL-10、TNF-α、IFN-γ、MCP-1）之间的差异。在随后的亚组患者（HA 组 10 例，对照组 11 例）中，我们进行了交叉吸附器以及凝血因子活性（抗凝血酶、血管性血友病因子、因子 II、V、VIII、IX、XI 和 XII）的连续测量。
两组在基线和围手术期特征方面相似。CPB 期间使用 Cytosorb®HA 并未增加不良事件的发生率。该操作并未导致凝血因子的显著吸附，仅出现一些凝血激活的迹象。然而，该干预措施既未导致促炎或抗炎细胞因子水平降低，也未改善相关临床结局。
CPB 期间使用 Cytosorb®HA 并未导致促炎或抗炎细胞因子水平降低，也未改善相关临床结局。该操作是可行且安全的。进一步的研究应评估 Cytosorb®HA 在其他临床情况下的疗效。
ClinicalTrials.gov NCT02775123。2016 年 5 月 17 日注册。
