This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic hollow fiber membrane cartridge. The device is connected in series to a commercially available CKRT hemofilter. Blood from the CKRT circuit is diverted after the CKRT hemofilter through to the extracapillary space (ECS) of the SCD cartridge. Blood circulates through the SCD ECS and then it is returned to the patient via the venous return line of the CKRT circuit. Regional citrate anticoagulation is used for the entire CKRT and SCD blood circuit. The SCD cartridge incorporates a synthetic hollow fiber membrane with the ability to bind activated leukocytes to its extracapillary surface; and when used in a CKRT extracorporeal circuit in the presence of regional citrate anticoagulation, the SCD modulates inflammation.
Standard of care CKRT for the subject's condition, as appropriate
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
NOT_YET_RECRUITINGCentral Arkansas Veterans Healthcare
Little Rock, Arkansas, United States
WITHDRAWNRonald Reagan UCLA Medical Center
Los Angeles, California, United States
NOT_YET_RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGComposite endpoint of mortality or dialysis dependency at 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
Time frame: 90 days
MAKE90
Major adverse kidney events at day 90 is a composite of death, need for KRT, or persistent renal dysfunction (final serum creatinine concentration, ≥200% of the baseline value) at the 90 day follow up period
Time frame: 90 days
Dialysis dependence
Need for any form of kidney replacement therapy at one year
Time frame: 1 year
ICU free days in the first 28 days
The number of days alive and requiring ICU level of care in the 28 days after randomization for at least 24 hours
Time frame: 28 days
Mortality at 28 days
Death by day 28 post randomization
Time frame: 28 days
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University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado, United States
WITHDRAWNAdventHealth Orlando
Orlando, Florida, United States
NOT_YET_RECRUITINGOrlando Regional Medical Center
Orlando, Florida, United States
WITHDRAWNJMS Burn Center
Augusta, Georgia, United States
WITHDRAWNUniversity of Iowa Hospital
Iowa City, Iowa, United States
RECRUITINGUniversity of Kentucky HealthCare
Lexington, Kentucky, United States
WITHDRAWN...and 23 more locations