title: The effect of the selective cytopheretic device on acute kidney injury outcomes in the intensive care unit: a multicenter pilot study.
abstract: 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.
authors.affiliation: Department of Medicine, College of Medicine, University of Tennessee, Chattanooga, TN Department of Medicine, George Washington University, Washington, DC Department of Medicine, University of Alabama, Birmingham, AL Department of Medicine, University of California, San Diego, CA Department of Medicine, Mayo Clinic, Rochester, MN Department of Medicine, University of Texas, Houston, TX Department of Medicine, Cytopherx, Inc., Ann Arbor, MI Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI Department of Medicine, University of Michigan, Ann Arbor, MI.
authors.forename: James A
authors.initials: JA
authors.lastname: Tumlin
authors.forename: Lakhmir
authors.initials: L
authors.lastname: Chawla
authors.forename: Ashita J
authors.initials: AJ
authors.lastname: Tolwani
authors.forename: Ravindra
authors.initials: R
authors.lastname: Mehta
authors.forename: John
authors.initials: J
authors.lastname: Dillon
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Finkel
authors.forename: J Ricardo
authors.initials: JR
authors.lastname: DaSilva
authors.forename: Brad C
authors.initials: BC
authors.lastname: Astor
authors.forename: Alexander S
authors.initials: AS
authors.lastname: Yevzlin
authors.forename: H David
authors.initials: HD
authors.lastname: Humes
mesh_terms: D058186:Acute Kidney Injury / Q000401:mortality / Q000628:therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017582:Renal Replacement Therapy; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult