RecruitingPhase 3NCT05399537

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)


Sponsor

Vantive Health LLC

Enrollment

40 participants

Start Date

Jul 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety of Prismocitrate 18 — a citrate-based solution used to prevent blood from clotting in tubes during continuous kidney replacement therapy (CRRT), a form of dialysis used in critically ill patients. It is designed for patients who cannot take heparin (a standard blood thinner). You may be eligible if: - You are 18 or older - You are a candidate for CRRT (continuous renal replacement therapy) - You have a contraindication to heparin or an increased risk of bleeding - You are expected to survive for at least 24 hours - You or your legal representative can provide written informed consent You may NOT be eligible if: - You have a known allergy to citrate or a history of citrate toxicity - You have acute liver failure or acute-on-chronic liver failure (Child-Pugh score above 10) - You have refractory shock with severe lactic acidosis (lactate above 4 mmol/L) - Your blood calcium level is outside the normal range and cannot be corrected - You are pregnant or breastfeeding - You are currently enrolled in another interventional clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrismocitrate 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.

DEVICEPrisMax 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

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NCT05399537


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