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RECRUITING
NCT05399537
PHASE3

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Sponsor: Vantive Health LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DEVICE

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