University of Szeged, Department of Anaesthesiology and Intensive Therapy, Szeged H-6725, 6. Semmelweis utca, Hungary.
University of Szeged, Department of Nephrology, H-6720 Szeged, Korányi fasor 8-10, Hungary.
J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.
The aim of this proof of concept, prospective, randomized pilot trial was to investigate the effects of extracorporeal cytokine removal (CytoSorb®) applied as a standalone treatment in patients with septic shock.
20 patients with early (<24 h) onset of septic shock of medical origin, on mechanical ventilation, norepinephrine>10 μg/min, procalcitonin (PCT) > 3 ng/mL without the need for renal replacement therapy were randomized into CytoSorb (n = 10) and Control groups (n = 10). CytoSorb therapy lasted for 24 h. Clinical and laboratory data were recorded at baseline (T), T, T, and T hours.
Overall SOFA scores did not differ between the groups. In the CytoSorb-group norepinephrine requirements and PCT concentration decreased significantly (norepinephrine: CytoSorb: T = 0.54[IQR:0.20-1.22], T = 0.16[IQR:0.07-0.48], p = .016; Controls: T = 0.43[IQR:0.19-0.64], T = 0.25[IQR:0.08-0.65] μg/kg/min; PCT: CytoSorb: T median = 20.6[IQR: 6.5-144.5], T = 5.6[1.9-54.4], p = .004; Control: T = 13.2[7.6-47.8], T = 9.2[3.8-44.2]ng/mL). Big-endothelin-1 concentrations were also significantly lower in the CytoSorb group (CytoSorb: T = 1.3 ± 0.6, *T = 1.0 ± 0.4, T = 1.4 ± 0.8, *p = .003; Control: T = 1.1 ± 0.7, T = 1.1 ± 0.6, T = 1.2 ± 0.6 pmol/L, p = .115). There were no CytoSorb therapy-related adverse events.
This is the first trial to investigate the effects of early extracorporeal cytokine adsorption treatment in septic shock applied without renal replacement therapy. It was found to be safe with significant effects on norepinephrine requirements, PCT and Big-endothelin-1 concentrations compared to controls.
The study has been registered on ClinicalTrials.gov, under the registration number of NCT02288975, registered 13 November 2014.
本概念验证、前瞻性、随机对照试验旨在研究体外细胞因子清除（CytoSorb®）作为单独治疗在感染性休克患者中的应用效果。
20 例起源于医学的早期（<24 小时）感染性休克患者，需要机械通气，去甲肾上腺素>10μg/min，降钙素原（PCT）>3ng/mL，不需要肾脏替代治疗，随机分为 CytoSorb 组（n=10）和对照组（n=10）。CytoSorb 治疗持续 24 小时。在基线（T）、T、T 和 T 小时记录临床和实验室数据。
两组患者 SOFA 评分总体无差异。CytoSorb 组去甲肾上腺素需求和 PCT 浓度显著下降（去甲肾上腺素：CytoSorb：T=0.54[IQR：0.20-1.22]，T=0.16[IQR：0.07-0.48]，p=0.016；对照组：T=0.43[IQR：0.19-0.64]，T=0.25[IQR：0.08-0.65]μg/kg/min；PCT：CytoSorb：T 中位数=20.6[IQR：6.5-144.5]，T=5.6[1.9-54.4]，p=0.004；对照组：T=13.2[7.6-47.8]，T=9.2[3.8-44.2]ng/mL）。CytoSorb 组大内皮素-1 浓度也显著降低（CytoSorb：T=1.3±0.6，*T=1.0±0.4，T=1.4±0.8，*p=0.003；对照组：T=1.1±0.7，T=1.1±0.6，T=1.2±0.6pmol/L，p=0.115）。CytoSorb 治疗无相关不良事件。
这是第一项研究在不进行肾脏替代治疗的情况下应用早期体外细胞因子吸附治疗感染性休克的疗效的试验。与对照组相比，它具有安全性，并且对去甲肾上腺素需求、PCT 和大内皮素-1 浓度有显著影响。
该研究已在 ClinicalTrials.gov 上注册，注册号为 NCT02288975，于 2014 年 11 月 13 日注册。
