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Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Sponsor: Vantive Health LLC
Summary
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.
Official title: A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-07-12
Completion Date
2026-12
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Prismocitrate 18
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.
PrisMax System Version 3.x with calcium line accessory
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.
Locations (14)
University of Alabama at Birmingham/UAB
Birmingham, Alabama, United States
University of Southern California (USC) / Keck Hospital
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, United States