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 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Must have AKI stage 2 or greater at the time of CKRT initiation.
Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
At least 18 years of age but not older than 80 at the time of enrollment.
One additional life-threatening organ dysfunction present.
Not expected to survive next 24 hours.
Anticipated transition to comfort measures or hospice in next 4 days.
Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
Parallel
Selective Cytopheretic Device
DeviceThe 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
Other interventionStandard of care CKRT for the subject's condition, as appropriate
Composite endpoint of mortality or dialysis dependency at 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
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
Dialysis dependence
Need for any form of kidney replacement therapy at one 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
Mortality at 28 days
Death by day 28 post randomization
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