title: A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.
abstract: OBJECTIVE
  Acute kidney injury (AKI) is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD) in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU).
  
  
  METHODS
  A randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT) alone and 65 received SCD therapy.
  
  
  RESULTS
  No significant difference in 60-day mortality was observed between the treated (27/69; 39%) and control patients (21/59; 36%, with six patients lost to follow up) in the intention to treat (ITT) analysis. Of the 19 SCD subjects (CRRT+SCD) and 31 control subjects (CRRT alone) who maintained a post-filter ionized calcium (iCa) level in the protocol's recommended range (≤ 0.4 mmol/L) for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19) in the SCD group compared to 41% (11/27) in the CRRT alone group (p = 0.11). Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r) iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16) and 25% (4/16), respectively (P = 0.10). When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01). The incidence of serious adverse events did not differ between the treated (45/69; 65%) and control groups (40/65; 63%; p = 0·86).
  
  
  CONCLUSIONS
  SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.
authors.affiliation: Department of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.
authors.forename: James A
authors.initials: JA
authors.lastname: Tumlin
authors.affiliation: Department of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.
authors.forename: Claude M
authors.initials: CM
authors.lastname: Galphin
authors.affiliation: Department of Medicine, UAB School of Medicine, University of Alabama, 1720 2nd Ave. S. FOT 1203, Birmingham, AL, 35294-3412, United States of America.
authors.forename: Ashita J
authors.initials: AJ
authors.lastname: Tolwani
authors.affiliation: Department of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America.
authors.forename: Micah R
authors.initials: MR
authors.lastname: Chan
authors.affiliation: Washington University School of Medicine, 660 S Euclid Ave., St Louis, MO, 63110, United States of America.
authors.forename: Anitha
authors.initials: A
authors.lastname: Vijayan
authors.affiliation: UT Health Science Center, University of Texas, 6410 Fannin St., Ste. 606, Houston, TX, 77030, United States of America.
authors.forename: Kevin
authors.initials: K
authors.lastname: Finkel
authors.affiliation: Henry Ford Health System, Henry Ford Hospital, CFP-509, 2799 West Grand Blvd., Detroit, MI, 48202-2608, United States of America.
authors.forename: Balazs
authors.initials: B
authors.lastname: Szamosfalvi
authors.affiliation: Dallas VA Medical Center, 4500 S. Lancaster Rd., Dallas, TX, 75216, United States of America.
authors.forename: Devasmita
authors.initials: D
authors.lastname: Dev
authors.affiliation: CytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America.
authors.forename: J Ricardo
authors.initials: JR
authors.lastname: DaSilva
authors.affiliation: Department of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America; Department of Population Health Sciences, University of Wisconsin, Health Sciences Learning Center, 750 Highland Ave., Madison, WI, 53705, United States of America.
authors.forename: Brad C
authors.initials: BC
authors.lastname: Astor
authors.affiliation: Department of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America; CytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America.
authors.forename: Alexander S
authors.initials: AS
authors.lastname: Yevzlin
authors.affiliation: CytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America; Department of Medicine, University of Michigan, 4520 MSRB I, Box 0651, 1150 W. Medical Center Drive, Ann Arbor, MI, 48109, United States of America.
authors.forename: H David
authors.initials: HD
authors.lastname: Humes
mesh_terms: D058186:Acute Kidney Injury / Q000628:therapy*; D000328:Adult; D000368:Aged; D003422:Critical Care; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D017582:Renal Replacement Therapy / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome