title: The effects of a novel therapeutic device on acute kidney injury outcomes in the intensive care unit: a pilot study.
abstract: 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).
authors.affiliation: Division of nephrology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Ding
authors.forename: Alexander S
authors.initials: AS
authors.lastname: Yevzlin
authors.forename: Z Y
authors.initials: ZY
authors.lastname: Xu
authors.forename: Y
authors.initials: Y
authors.lastname: Zhou
authors.forename: Q H
authors.initials: QH
authors.lastname: Xie
authors.forename: J F
authors.initials: JF
authors.lastname: Liu
authors.forename: Y
authors.initials: Y
authors.lastname: Zheng
authors.forename: J Ricardo
authors.initials: JR
authors.lastname: DaSilva
authors.forename: H D
authors.initials: HD
authors.lastname: Humes
mesh_terms: D058186:Acute Kidney Injury / Q000628:therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003422:Critical Care / Q000379:methods*; D018795:Device Approval; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration