NCT05399537 · Vantive Health LLC
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium \< 0.9 mmol/L.
Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium \> 1.4 mmol/L.
Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio \> 2.5.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Los Angeles, California
- Miami, Florida
- Atlanta, Georgia
- Ann Arbor, Michigan
- Springfield, Ohio
- Danville, Pennsylvania
- Hershey, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Memphis, Tennessee
- Dallas, Texas
And 1 more location — see the full list below.
Collaborators
Baxter Healthcare Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations