细胞因子吸附剂血液灌注治疗去甲肾上腺素耐药脓毒性休克的临床疗效:清洁随机临床试验方案

Nattapat Wongtirawit, Phitphiboon Deawtrakulchai, Anupol Panitchote, R. Ratanarat
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引用次数: 0

摘要

背景:由于炎症细胞因子在脓毒症中的关键作用,细胞因子吸附剂的血液灌流可能会带来更好的结果。虽然先前的研究显示不确定的结果,但适当的患者选择和血液灌流的时机可能会提高生存率。目的:探讨需要大剂量血管加压药物的脓毒性休克患者接受细胞因子吸附剂血液灌流是否比单纯接受标准治疗的患者有更好的临床结果。方法:这是一项在2个三级保健中心进行的多中心、随机对照研究。206例接受0.2 mcg/kg/min或更高去甲肾上腺素治疗的脓毒性休克患者随机分为两组,一组接受标准治疗,另一组连续两天接受3小时细胞因子吸附剂血液灌注(HP组),另一组单独接受标准治疗(ST组)。主要终点是28天死亡率。次要结局包括医院和ICU死亡率、休克逆转、血管活性-肌力评分(VIS)、无器官支持天数、白细胞介素-6水平以及安全性数据。结论:本研究将为指导脓毒性休克患者使用细胞因子吸附剂进行血液灌流提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical efficacy of hemoperfusion with a cytokine adsorbent in norepinephrine-resistant septic shock: protocol for the CLEANSE randomized clinical trial
Background: Due to the pivotal role of inflammatory cytokines in sepsis, hemoperfusion with cytokine adsorbents may lead to better outcomes. Although previous studies showed inconclusive results, proper patient selection and timing of hemoperfusion may lead to improved survival. Objectives: To examine whether patients with septic shock requiring high-dose vasopressors undergoing add-on hemoperfusion with a cytokine adsorbent have better clinical outcomes than those treated with standard treatment alone. Methods: This is a multi-center, randomized controlled study in 2 tertiary care centers. 206 patients with septic shock receiving norepinephrine of 0.2 mcg/kg/min or higher are randomized to receive either standard treatment combined with 3-hour sessions of hemoperfusion with cytokine adsorbent for two consecutive days (HP group) or standard treatment alone (ST group). The primary outcome is 28-day mortality. Secondary outcomes include hospital and ICU mortality, shock reversal, vasoactive-inotropic score (VIS), organ support-free days, interleukin-6 levels, as well as safety data. Conclusions: This study will provide information to guide the use of hemoperfusion with a cytokine adsorbent in patients with septic shock.
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