Clinical trial NCT05399537: Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Official title: A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Regional Citrate Anticoagulation (RCA)
Continuous Renal Replacement Therapy (CRRT)
Acute Kidney Injury (AKI)
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration
timeFrame: Day 1 up to Day 10
measure: Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration
timeFrame: Day 1 up to Day 10
measure: Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration
timeFrame: Day 1 up to Day 10
Secondary outcomes:
measure: Number of participants with Adverse Events related to study product and/or procedure
timeFrame: Day 1 up to Day 28
measure: Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x
timeFrame: Day 1 up to Day 10
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California (USC) / Keck Hospital
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Springfield
country: United States
facility: Bon Secours Mercy Health-Springfield Regional Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Memphis
country: United States
facility: Lt. Col. Luke Weathers, Jr. VA Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: McAllen
country: United States
facility: Gamma Medical Research, Inc / McAllen Medical Center
state: Texas
Study officials:
References: