Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Public ClinicalTrials.gov record NCT05399537. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05399537
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2024 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Jan 2027 (Estimated)
- Last update posted
- Oct 5, 2026
2024 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham/UAB | Birmingham | Alabama | 35294-0007 | Recruiting |
| University of Southern California (USC) / Keck Hospital | Los Angeles | California | 90033 | Recruiting |
| University of California Los Angeles | Los Angeles | California | 90095 | Withdrawn |
| University of Miami | Miami | Florida | 33136 | Not yet recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Recruiting |
| Bon Secours Mercy Health-Springfield Regional Medical Center | Springfield | Ohio | 45504 | Terminated |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Withdrawn |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | Withdrawn |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | Terminated |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Recruiting |
| Lt. Col. Luke Weathers, Jr. VA Medical Center | Memphis | Tennessee | 38104 | Recruiting |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | Recruiting |
| Gamma Medical Research, Inc / McAllen Medical Center | McAllen | Texas | 78503 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05399537, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05399537 live on ClinicalTrials.gov.