Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure

Inclusion criteria

• . A patient, or legal representative, has signed a written informed consent form.
• . Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma, Mixed, other).
• . Age 18 to 80 years.
• . Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
• . Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24 hours.
• . Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
• . A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as acute renal failure occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average \<20 mL/hr) for \>6-12 hours or: an increase in serum creatinine ≥2 mg/dL (≥1.5 mg/dL in females) over a period of ≤4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)
• . At least one non-renal organ failure (modified SOFA organ system score \>2), as defined in Appendix A or presence (proven or suspected) of sepsis as defined in Appendix B.

Exclusion criteria