Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR)

Vantive Health LLC

Status: Enrolling

Conditions: Renal Insufficiency

Treatments: Drug: Biphozyl; Drug: Prismasol 2; Drug: Regiocit

Study type: Observational

Funder types: Industry

Identifiers

NCT06983509

BXU605703

Details and patient eligibility

About

This is a multicenter, prospective, registry study. By collecting relevant demographic information and clinical data of patients receiving continuous renal replacement therapy (CRRT) with pre-mixed solutions, the clinical applicability of pre-mixed solutions will be evaluated in critically ill patients in real-world clinical settings.

This study will be carried out in approximately 10 study sites in China. Patient data will be collected to evaluate the clinical applicability of pre-mixed solutions.

Full description

Treatment observation period: From initiation of the first CRRT with sponsored pre-mixed solutions to cessation of the pre-mixed solutions. The duration of this period can be up to 10 days.

Follow-up period: from the cessation of sponsored pre-mixed solutions to Day 30 after starting treatment with the pre-mix solutions.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 ≤ age < 80 years old.
• Patients admitted to the intensive care unit (ICU) and in need of CRRT.
• Patients are willing to receive CRRT with at least one of three pre-mixed solutions:

Regiocit, Biphozyl, or Prismasol 2.

Exclusion criteria

• Patients with chronic kidney failure who are receiving maintenance dialysis.
• Patients expected to require the premixed solution for less than 24 hours.
• Patients who are allergic or have contraindications to components of pre-mixed solutions, as determined by the investigators.
• Patients who have participated in other interventional studies within the last 30 days.
• Patients who are pregnant, breastfeeding, or abortus imminence.

Trial design

220 participants in 1 patient group

CRRT with Regiocit/Prismasol 2/Biphozyl

Description:

Critically ill adult patients receiving CRRT with at least one of the three pre-mixed solutions (Regiocit, Prismasol 2, or Biphozyl). The mode of therapy, solute formulations, flow rates, fluid removal rate, and length of therapy is selected by the physician responsible for managing treatment, depending on the clinical condition of the patient, as well as the patient's fluid, electrolyte, acid-base, and glucose balance. An initial CRRT dose of 30 mL/kg/h is advised to achieve the recommended effluent volume of 20 to 25 mL/kg/h. Patients weighing more than 100 kg may not exceed a CRRT dose of 4 L/h.

Treatment:

Drug: Regiocit

Drug: Prismasol 2

Drug: Biphozyl