Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
NCT ID: NCT05399537
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2024-07-12
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory
This is a single-arm study. Patients will receive regional citrate anticoagulation (RCA) with Prismocitrate 18 (investigational drug) during their CRRT treatment using the PrisMax System Version 3.x with calcium line accessory (investigational device).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BXU558476
Identifier Type: -
Identifier Source: org_study_id