The Effect of the Selective Cytopheretic Device on Acute Kidney Injury Outcomes in the Intensive Care Unit: A Multicenter Pilot Study
The Effect of the Selective Cytopheretic Device on Acute Kidney Injury Outcomes in the Intensive Care Unit: A Multicenter Pilot Study
复制标题
DOI：
10.1111/sdi.12032
复制
发表时间：
2013-09-01
影响因子：
1.6
通讯作者：
Humes, H. David
中科院分区：
文献类型：
--
作者：
Tumlin, James A.;Chawla, Lakhmir;Humes, H. David
急性肾损伤（阿基）的特征是肾功能恶化，导致多系统异常。与阿基相关的大部分发病率和死亡率是由全身炎症反应综合征（SIRS）引起的。本文所述研究是一项前瞻性、单组、多中心美国研究，旨在评价选择性细胞分裂装置（SCD）治疗ICU中需要连续性肾脏替代治疗（CRRT）的阿基的安全性和有效性。该研究招募了35名受试者。平均年龄为56.3 ± 15岁。关于人种，71.4%的受试者为白人，22.9%为黑人，5.7%为西班牙裔。平均SOFA评分为11.3 +/- 3.6。第60天全因死亡率为31.4%。第60天，在所有存活受试者中观察到肾脏恢复（定义为不依赖透析）。该初步研究的结果表明，与标准治疗相比，患者结局有可能得到实质性改善，在文献中，标准治疗与超过50%的60天死亡率相关。SCD需要在科学合理的关键试验中进行进一步研究，以证明安全性和有效性的合理保证。
Acute kidney injury (AKI) is characterized by deterioration in kidney function resulting in multisystem abnormalities. Much of the morbidity and mortality associated with AKI result from a systemic inflammatory response syndrome (SIRS). This study described herein is a prospective, single-arm, multicenter US study designed to evaluate the safety and efficacy of the Selective Cytopheretic Device (SCD) treatment on AKI requiring continuous renal replacement therapy (CRRT) in the ICU. The study enrolled 35 subjects. The mean age was 56.3 +/- 15. With regard to race, 71.4% of the subjects were Caucasian, 22.9% were Black, and 5.7% were Hispanic. Average SOFA score was 11.3 +/- 3.6. Death from any cause at Day 60 was 31.4%. Renal recovery, defined as dialysis independence, was observed in all of the surviving subjects at Day 60. The results of this pilot study indicate the potential for a substantial improvement in patient outcomes over standard of care therapy, which is associated with a greater than 50% 60-day mortality in the literature. The SCD warrants further study in scientifically sound, pivotal trial to demonstrate reasonable assurance of safety and effectiveness.