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Safety of Prismocitrate 18 in CRRT Patients

This study is evaluating the safety of Prismocitrate 18, a solution used during Continuous Renal Replacement Therapy (CRRT) for acute kidney injury (AKI). Prismocitrate 18 acts as both a kidney replacement solution and an anticoagulant to prevent blood clots in the CRRT machine. It's used with the PrisMax System, which has special software to help manage citrate and calcium levels. Researchers want to see how many participants experience problems like low calcium (hypocalcemia), high calcium (hypercalcemia), or too much citrate in their body when using Prismocitrate 18. You might be able to join if you are 18 or older, need CRRT, are expected to live at least 24 hours, and cannot use heparin for anticoagulation. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study involving approximately 40 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for symptomatic hypocalcemia, hypercalcemia, and citrate accumulation from Day 1 up to Day 10.

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NCT05399537

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Recruiting
PHASE3Ages 18+InterventionalTreatment
Vantive Health LLC
~40 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Prismocitrate 18PrisMax System Version 3.x with calcium line accessory

At a glance

Recruiting sites
5 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration
Measured over Day 1 up to Day 10
+2 more outcomes measured

Conditions

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

Explore related trials

Acute Renal Failure

Where it's being run

14 sites across 10 states
Pennsylvania3
California2
Texas2
Alabama1
Florida1
Georgia1
Michigan1
Ohio1

Who to contact

Global CORP Clinical Trials Disclosure
[email protected]
+1 2249484283
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administrationDay 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 administrationDay 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 administrationDay 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.