Department of Anesthesiology and Intensive Care, University of Szeged, Szeged, Hungary.
Department of Anaesthesia and Critical Care, Fundeni Clinical Institute, Bucharest, Romania.
PLoS One. 2022 Oct 25;17(10):e0274315. doi: 10.1371/journal.pone.0274315. eCollection 2022.
The aim of the current paper is to summarize the results of the International CytoSorb Registry. Data were collected on patients of the intensive care unit. The primary endpoint was actual in-hospital mortality compared to the mortality predicted by APACHE II score. The main secondary endpoints were SOFA scores, inflammatory biomarkers and overall evaluation of the general condition. 1434 patients were enrolled. Indications for hemoadsorption were sepsis/septic shock (N = 936); cardiac surgery perioperatively (N = 172); cardiac surgery postoperatively (N = 67) and "other" reasons (N = 259). APACHE-II-predicted mortality was 62.0±24.8%, whereas observed hospital mortality was 50.1%. Overall SOFA scores did not change but cardiovascular and pulmonary SOFA scores decreased by 0.4 [-0.5;-0.3] and -0.2 [-0.3;-0.2] points, respectively. Serum procalcitonin and C-reactive protein levels showed significant reduction: -15.4 [-19.6;-11.17] ng/mL; -17,52 [-70;44] mg/L, respectively. In the septic cohort PCT and IL-6 also showed significant reduction: -18.2 [-23.6;-12.8] ng/mL; -2.6 [-3.0;-2.2] pg/mL, respectively. Evaluation of the overall effect: minimal improvement (22%), much improvement (22%) and very much improvement (10%), no change observed (30%) and deterioration (4%). There was no significant difference in the primary outcome of mortality, but there were improvements in cardiovascular and pulmonary SOFA scores and a reduction in PCT, CRP and IL-6 levels. Trial registration: ClinicalTrials.gov Identifier: NCT02312024 (retrospectively registered).
本文旨在总结国际细胞吸附器注册研究的结果。数据采集自重症监护病房的患者。主要终点是实际院内死亡率与急性生理与慢性健康评分(APACHE II)预测死亡率的比较。主要次要终点为 SOFA 评分、炎症生物标志物和一般状况的整体评估。共纳入 1434 例患者。血液吸附的适应证为脓毒症/感染性休克(N=936);心脏手术围手术期(N=172);心脏手术后(N=67)和“其他”原因(N=259)。APACHE II 预测死亡率为 62.0±24.8%,而观察到的院内死亡率为 50.1%。总体 SOFA 评分无变化,但心血管和肺部 SOFA 评分分别下降 0.4[-0.5;-0.3]和 -0.2[-0.3;-0.2]分。血清降钙素原和 C 反应蛋白水平显著降低:-15.4[-19.6;-11.17]ng/mL;-17.52[-70;44]mg/L,分别。在脓毒症组中 PCT 和 IL-6 也显著降低:-18.2[-23.6;-12.8]ng/mL;-2.6[-3.0;-2.2]pg/mL,分别。整体效果评估:轻微改善(22%)、明显改善(22%)和非常明显改善(10%)、无变化(30%)和恶化(4%)。死亡率这一主要结局无显著差异,但心血管和肺部 SOFA 评分有所改善,PCT、CRP 和 IL-6 水平降低。试验注册:ClinicalTrials.gov 标识符:NCT02312024(回顾性注册)。