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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Prismocitrate 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.
The 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.
University of Alabama at Birmingham/UAB
Birmingham, Alabama, United States
NOT_YET_RECRUITINGUniversity of Southern California (USC) / Keck Hospital
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of Miami
Miami, Florida, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGBon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, United States
RECRUITINGGeisinger Medical Center
Danville, Pennsylvania, United States
NOT_YET_RECRUITINGPenn State Hershey Medical Center
Hershey, Pennsylvania, United States
WITHDRAWNVA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
RECRUITING...and 4 more locations
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.
Time frame: Day 1 up to Day 10
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.
Time frame: Day 1 up to Day 10
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.
Time frame: Day 1 up to Day 10
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
Time frame: Day 1 up to Day 28
Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x
Percentage of complete RCA treatments according to protocol
Time frame: Day 1 up to Day 10
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