The Selective Cytopheretic Device (SCD) for Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I

Exclusion Criteria

• •Evidence of chronic kidney disease Stage 4.
• •Patients with Model for End-Stage Liver Disease (MELD) score \> 40 (since these patients are unlikely to survive a 90-day follow-up period).
• •Acute or chronic use of circulatory support device.
• •Mechanical ventilation for greater than 7 consecutive days.
• •AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity. No evidence of intrinsic parenchymal renal disorder, ultrasonic evidence of obstructive uropathy or proteinuria greater than 500 mg/day.
• •Presence of any organ transplant at any time.
• •Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study protocol therapy.
• •Severe, uncontrolled cardiac disease.
• •Chronic immunosuppression.
• •Medical history of HIV or AIDS.
• •Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days.
• •Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
• •Dry weight \>150 kg.
• •Platelet count \<30,000/mm3.
• •Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
• •Use of any other investigational drug or device within the previous 30 days
• •Patient is a prisoner.