Actively Recruiting
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Led by Vantive Health LLC · Updated on 2026-04-13
40
Participants Needed
14
Research Sites
124 weeks
Total Duration
On this page
Sponsors
V
Vantive Health LLC
Lead Sponsor
B
Baxter Healthcare Corporation
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 60;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)
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University of Alabama at Birmingham/UAB
Birmingham, Alabama, United States, 35294-0007
Actively Recruiting
2
University of Southern California (USC) / Keck Hospital
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Withdrawn
4
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
7
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, United States, 45504
Actively Recruiting
8
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Not Yet Recruiting
9
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Withdrawn
10
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Active, Not Recruiting
11
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
12
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, United States, 38104
Actively Recruiting
13
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Not Yet Recruiting
14
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, United States, 78503
Active, Not Recruiting
Research Team
G
Global CORP Clinical Trials Disclosure
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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