The Effects of a Novel Therapeutic Device on Acute Kidney Injury Outcomes in the Intensive Care Unit: A Pilot Study
The Effects of a Novel Therapeutic Device on Acute Kidney Injury Outcomes in the Intensive Care Unit: A Pilot Study
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DOI：
10.1097/mat.0b013e31820a1494
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发表时间：
2011-09-01
期刊：
影响因子：
4.2
通讯作者：
Humes, H. D.
中科院分区：
文献类型：
--
作者：
Ding, Feng;Yevzlin, Alexander S.;Humes, H. D.
尽管肾脏替代疗法的提供已有数十年的改进，但重症监护室（ICU）环境中与急性肾损伤（阿基）相关的发病率和死亡率仍然极高。这种疾病的大部分发病率和死亡率是由免疫失调引起的全身性细胞损伤的结果。这是一项前瞻性、单组、单中心研究，旨在评价选择性细胞移植器械（SCD）对ICU中需要肾脏替代治疗的阿基患者临床结局的安全性和有效性。在年龄和序贯器官衰竭评估（SOFA）评分方面，将入组试验的患者与历史病例匹配的对照组进行比较。病例匹配对照组的死亡率为77.78%，而SCD治疗组的死亡率为22.22%（p = 0.027）。多元回归分析确定SCD治疗是影响年龄、SOFA评分、治疗期间或治疗后前7天尿量平均变化的唯一显著变量。接受SCD治疗的10例受试者的平均总尿量从基线约500 ml/d增加至治疗第7天超过2，000 ml/d。SCD代表了一种改变阿基中观察到的急性炎症反应的新型治疗方法，根据美国食品药品监督管理局（FDA）批准的试验用器械豁免（IDE），正在美国进行的一项多中心研究中对该器械的安全性和有效性进行进一步评价。ASAIO Journal 2011; 57：426-432.
Despite decades of improvements in the provision of renal replacement therapy, the morbidity and mortality associated with acute kidney injury (AKI) in the intensive care unit (ICU) setting remains extremely high. Much of the morbidity and mortality of this disorder is the consequence of systemic cellular damage that results from immune dysregulation. This is a prospective, single-arm, single-center study designed to evaluate the safety and efficacy of treatment with a selective cytopheretic device (SCD) on clinical outcomes in AKI requiring renal replacement therapy in the ICU. The patients enrolled in the trial were compared with historical case-matched controls with respect to age and Sequential Organ Failure Assessment (SOFA) score. The mortality for the case-matched controls was 77.78%, whereas the mortality in the SCD treatment group was 22.22% (p = 0.027). Multiple regression analysis identified treatment with SCD as the only significant variable affecting mortality among age, SOFA score, average change in urine output over the first 7 days during or after treatment. Mean total urine output in the 10 subjects receiving SCD treatment increased from a baseline of approximately 500 ml/d to more than 2,000 ml/d by day 7 of treatment. The SCD represents a novel therapeutic approach to alter the acute inflammatory response seen in AKI, and further evaluation of the safety and efficacy of the device is being evaluated in a multicenter investigation in the United States under an Food and Drug Administration (FDA) approved investigational device exemption (IDE). ASAIO Journal 2011; 57:426-432.