Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Prismocitrate 18
  Prismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.
• Устройство PrisMax System Version 3.x with calcium line accessory
  The RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation.

Первичные конечные точки

• Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration [Срок оценки: Day 1 up to Day 10]
• Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration [Срок оценки: Day 1 up to Day 10]
• Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration [Срок оценки: Day 1 up to Day 10]

Вторичные конечные точки (2)

• Number of participants with Adverse Events related to study product and/or procedure [Срок оценки: Day 1 up to Day 28]
• Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x [Срок оценки: Day 1 up to Day 10]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• University of Alabama at Birmingham/UAB — Birmingham
• University of Southern California (USC) / Keck Hospital — Los Angeles
• University of California Los Angeles — Los Angeles
• University of Miami — Miami
• Emory University — Atlanta
• University of Michigan — Ann Arbor
• Bon Secours Mercy Health-Springfield Regional Medical Center — Springfield
• Geisinger Medical Center — Danville
• … и ещё 6 центров

Идентификаторы

NCT: NCT05399537 · BXU558476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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