RECRUITING

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

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Conditions

Regional Citrate Anticoagulation (RCA)Continuous Renal Replacement Therapy (CRRT)Acute Kidney Injury (AKI)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)

Quick Facts

Study Start:2024-07-12
Study Completion:2026-05-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05399537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be ≥18 years of age
  2. * Patients who are candidates for CRRT
  3. * Patients expected to survive for at least 24 hours
  4. * Patients with a contraindication to heparin or an increased risk of hemorrhage
  5. * Patient and/or legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e)
  1. * 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
  2. * 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
  3. * Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10
  4. * Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L)
  5. * 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)
  6. * 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)
  7. * Patients who are currently participating in another interventional clinical study

Contacts and Locations

Study Contact

Global CORP Clinical Trials Disclosure
CONTACT
+1 2249484283
Global.CORP.ClinicalTrialsDisclosure@vantive.com

Study Locations (Sites)

University of Southern California (USC) / Keck Hospital
Los Angeles, California, 90033
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, 45504
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, 38104
United States
Methodist Dallas Medical Center
Dallas, Texas, 75203
United States
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, 78503
United States

Collaborators and Investigators

Sponsor: Vantive Health LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12
Study Completion Date2026-05-26

Study Record Updates

Study Start Date2024-07-12
Study Completion Date2026-05-26

Terms related to this study

Additional Relevant MeSH Terms

  • Regional Citrate Anticoagulation (RCA)
  • Continuous Renal Replacement Therapy (CRRT)
  • Acute Kidney Injury (AKI)