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NCT05399537PHASE3Recruiting

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Vantive Health LLC

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

Inclusion Criteria: * Patients must be ≥18 years of age * Patients who are candidates for CRRT * Patients expected to survive for at least 24 hours * Patients with a contraindication to heparin or an increased risk of hemorrhage * Patient and/or legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e) Exclusion Criteria: * Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity * Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease * Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10 * Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L) * Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation) * Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic \[B-hCG\] pregnancy test at Screening) * Patients who are currently participating in another interventional clinical study

Interventions

DRUG

Prismocitrate 18

DEVICE

PrisMax System Version 3.x with calcium line accessory

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Conditions

Regional Citrate Anticoagulation (RCA)Continuous Renal Replacement Therapy (CRRT)Acute Kidney Injury (AKI)

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