Clinical Trial

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Recruiting Phase 3
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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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2022-05-27; most recent amendment 2026-07-24.
Status change: Not Yet Recruiting → Recruiting 2024-04-13
Trial Details
NCT Number NCT05399537
Lead Sponsor Vantive Health LLC
Collaborators: Baxter Healthcare Corporation
Conditions Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
Enrollment 40 participants
Start Date 2024-07-12
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-27