Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Inclusion Criteria:

• Patients must be ≥18 years of age

• Patients who are candidates for CRRT

• Patients expected to survive for at least 24 hours

• Patients with a contraindication to heparin or an increased risk of hemorrhage

• Patient and/or legally-authorized representative has signed a written informedconsent form (ICF) per 21 CFR Part 50.55(e)

Exclusion Criteria:

• Patients with a known allergy to citrate or who have ever experienced an adversereaction associated with citrate products, including patients with a prior historyof citrate toxicity

• Patients with acute liver failure, defined by the occurrence of encephalopathy andhepatic synthetic dysfunction within 26 weeks of the first symptoms of liver diseaseand without evidence of chronic liver disease

• Patients with acute-on-chronic liver failure characterized by acute decompensationof cirrhosis and a Child-Pugh Liver Failure Score >10

• Patients with refractory shock and associated lactic acidosis (lactate >4 mmol/L)

• Patients with a systemic ionized calcium concentration outside the normalphysiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment forhypercalcemia to achieve a normal physiologic range prior to therapy initiation)

• Female patients of childbearing potential who are pregnant or breastfeeding. (Note:All female patients, who have not undergone a hysterectomy, bilateral oophorectomywith or without hysterectomy, or has medically documented ovarian failure beforestudy Screening must have a negative serum beta human chorionic gonadotropic [B-hCG]pregnancy test at Screening)

• Patients who are currently participating in another interventional clinical study