Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription.
The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH) and 2) to observe that the software and interface for the PrisMax System Version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (RCA) (citrate and calcium dosing) during CRRT with Prismocitrate 18 and intended prescription.
The study period of the patient's CRRT will be up to 10 days.
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
Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity
Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease
Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score >10
Patients with refractory shock and associated lactic acidosis (lactate >4 mmol/L)
Single group
Prismocitrate 18
DrugPrismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.35 mmol/L.
PrisMax System Version 3.x with calcium line accessory
DeviceThe RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation.
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration
Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium \< 0.9 mmol/L.
Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration
Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium \> 1.4 mmol/L.
Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration
Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio \> 2.5.
Number of participants with Adverse Events related to study product and/or procedure
Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section
Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x
Percentage of complete RCA treatments according to protocol
Click on the lead sponsor to view all of their trials.
Vantive Health LLC
Lead sponsor
Baxter Healthcare Corporation
Collaborator
