Schädler Dirk, Pausch Christine, Heise Daniel, Meier-Hellmann Andreas, Brederlau Jörg, Weiler Norbert, Marx Gernot, Putensen Christian, Spies Claudia, Jörres Achim, Quintel Michael, Engel Christoph, Kellum John A, Kuhlmann Martin K
Department of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.
PLoS One. 2017 Oct 30;12(10):e0187015. doi: 10.1371/journal.pone.0187015. eCollection 2017.
We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure.
This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7.
97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19).
In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.
我们报告血液吸附疗法对降低呼吸衰竭脓毒症患者细胞因子水平的效果。
这是一项随机、对照、开放标签的多中心试验。符合入选标准的患者为机械通气的严重脓毒症或脓毒症休克患者，且伴有急性肺损伤或急性呼吸窘迫综合征。患者被随机分为两组，一组接受每天6小时的CytoSorb血液灌流治疗，持续7天（治疗组），另一组不进行血液灌流（对照组）。主要结局指标是研究第1天和第7天标准化IL-6血清浓度的变化。
对100例随机分组患者中的97例进行了分析。我们未能检测到两组间全身血浆IL-6水平的差异（n = 75；p = 0.15）。在整个治疗期间，每次血液灌流平均有5%至18%的IL-6被有效清除。在未调整分析中，治疗组60天死亡率（44.7%）显著高于对照组（26.0%；p = 0.039）。与对照组（16.3%）相比，治疗组入组时接受肾脏替代治疗的患者比例更高（31.9%）。在对患者发病率和基线不平衡进行调整后，未发现血液灌流与死亡率之间存在关联（p = 0.19）。
在这个以脓毒症休克和多器官功能衰竭为主的患者群体中，血液吸附可清除IL-6，但这并未导致血浆IL-6水平降低。我们未检测到在次要结局指标多器官功能障碍评分、通气时间和氧合时间过程方面存在统计学显著差异。
