Evaluating the safety of Prismocitrate 18 for patients on continuous renal replacement therapy
A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
This study is testing if a new solution called Prismocitrate 18 is safe for patients on a special type of kidney treatment to help prevent blood clots during their therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vantive Health LLC Industry-sponsored |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT05399537 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of Prismocitrate 18, a solution used in continuous renal replacement therapy (CRRT), specifically for patients undergoing continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH). The study aims to confirm that the PrisMax System, equipped with regional citrate anticoagulation (RCA) software, can safely manage citrate and calcium dosing during CRRT. Participants will receive treatment for up to 10 days, with a focus on preventing blood clotting in the extracorporeal circuit.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are candidates for CRRT and have contraindications to heparin or an increased risk of hemorrhage.
Not a fit: Patients with known allergies to citrate or those with acute liver failure or refractory shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficacy of anticoagulation in patients receiving CRRT, potentially leading to better patient outcomes.
How similar studies have performed: Other studies have explored citrate anticoagulation in CRRT, indicating a promising approach, but the specific use of Prismocitrate 18 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama at Birmingham/UAB — Birmingham, Alabama, United States (Recruiting)
- University of Southern California (USC) / Keck Hospital — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, California, United States (Withdrawn)
- University of Miami — Miami, Florida, United States (Not_yet_recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Bon Secours Mercy Health-Springfield Regional Medical Center — Springfield, Ohio, United States (Recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Not_yet_recruiting)
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Withdrawn)
- VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (Not_yet_recruiting)
- Lt. Col. Luke Weathers, Jr. VA Medical Center — Memphis, Tennessee, United States (Recruiting)
- Methodist Dallas Medical Center — Dallas, Texas, United States (Not_yet_recruiting)
- Gamma Medical Research, Inc / McAllen Medical Center — McAllen, Texas, United States (Active_not_recruiting)
Study contacts
- Study coordinator: Global CORP Clinical Trials Disclosure
- Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com
- Phone: +1 2249484283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.