Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Inclusion Criteria:

1. Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical
ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).

2. Adult patients with AKI or other serious conditions who require treatment with CRRT.

3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after
randomization.

4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of
initiation of their standard-of-care CRRT.

Exclusion Criteria:

1. Patients requiring systemic anticoagulation with antithrombotic agents for reasons
other than CRRT. The exception is patients receiving subcutaneous heparin for deep
vein thrombosis prophylaxis according to institutional practice or patients on aspirin
may be enrolled.

2. Patients in whom citrate anticoagulation is contraindicated such as patients with a
known allergy to citrate or who have experienced adverse events associated with
citrate products including patients with a prior history of citrate toxicity or
patients with uncorrected severe hypocalcemia (whether in the context of current
citrate administration or due to the underlying disease state).

3. Patients who are not candidates for CRRT.

4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.

5. Patients with severe coagulopathy [i.e., platelets < 30,000/mm3, international
normalized ratio (INR) > 2, partial thromboplastin time (PTT) > 50 seconds] including
severe thrombocytopenia (platelets < 30,000/mm3), HIT (heparin induced
thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic
thrombocytopenia purpura) should not be enrolled in the trial.

6. Patients with fulminant acute liver failure or acute on chronic liver failure as
documented by a Child-Pugh Liver Failure Score > 10.

7. Patients with refractory shock associated persistent, worsening with lactic acidosis
(lactate > 4 mmol/L). However, patients with improving subsequent serum lactate levels
may be enrolled.

8. Patients unlikely to survive at least 72 hours.

9. Female patients who are pregnant, lactating, or planning to become pregnant during the
study period.

10. Patients who are currently participating in another interventional clinical study.

11. Patients with a medical condition that may interfere with the study objectives.