Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Condition: Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT); Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Intervention: Prismocitrate 18; No Anticoagulation
Intervention description: Modality of CVVHDF; Modality of CVVHDF
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT); Acute Kidney Injury

Summary:

      The purpose of this research is to determine if an investigational new drug solution called
      Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous
      renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18
      as the anticoagulant will be compared to patients who receive CRRT treatment with no
      anticoagulation.
    

Eligibility criteria:

        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.