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.