Evaluating the safety of Prismocitrate 18 for patients on continuous renal replacement therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham/UAB
  Birmingham, Alabama, United States Recruiting
• University of Southern California (USC) / Keck Hospital
  Los Angeles, California, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Medical University of South Carolina (MUSC)
  Charleston, South Carolina, United States Recruiting
• Lt. Col. Luke Weathers, Jr. VA Medical Center
  Memphis, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Global CORP Clinical Trials Disclosure
• Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com
• Phone: +1 2249484283

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Levetiracetam Dosing in Critically Ill on CRRT

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• High vs standard protein intake in critically ill adults with acute kidney injury on CRRT

  This study tests whether a higher protein diet helps adult ICU patients with acute kidney injury who are receiving continuous renal replacement therapy.

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• Citrate anticoagulation protocol to stabilize electrolytes during continuous renal replacement in ICU adults

  This test tries to see if a modified CRRT method using citrate anticoagulation with post-filter replacement keeps electrolytes more stable and reduces the need for supplements in adult ICU patients with acute kidney injury.

  Recruiting Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona, Barcelona · NCT07514650

• Low- versus high-dose nafamostat for anticoagulation during CRRT in ICU patients

  This study tests whether starting nafamostat at 50 mg/h rather than 20 mg/h keeps CRRT filters from clotting longer in adult ICU patients on continuous renal replacement therapy.

  Recruiting Phase 2 Zhujiang Hospital · Guangzhou, Guangdong · NCT07469072

• Fluid balance guided by mVExUS in ICU patients on CRRT with acute kidney injury

  This trial tests whether using modified venous excess ultrasound (mVExUS) to guide fluid removal in ICU patients on CRRT with AKI can achieve a better fluid balance in the first 72 hours compared with standard care.

  Recruiting Chulalongkorn University · Bangkok and 1 other locations · NCT07346118

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.