Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Start Date
7/12/2024
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Prismocitrate 18
PrisMax System Version 3.x with calcium line accessory
Conditions
Locations
University of Alabama at Birmingham/UAB
Birmingham, Alabama 35294-0007
United States
University of Southern California (USC) / Keck Hospital
Los Angeles, California 90033
United States
University of California Los Angeles
Los Angeles, California 90095
United States
University of Miami
Miami, Florida 33136
United States
Emory University
Atlanta, Georgia 30322
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio 45504
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania 15240
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee 38104
United States
Methodist Dallas Medical Center
Dallas, Texas 75203
United States
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas 78503
United States