NCT06983509

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

Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy (PrioR): a Multicenter, Prospective Real-world

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 228 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Regiocit	Regiocit can be used as a replacement fluid for CRRT with RCA. It will be used in pre-dilution mode only. At least 200 mL of post-replacement solution is recommended to minimize clotting in the de-aeration chamber. A replacement/dialysate solution with 22 to 26 mEq/L bicarbonate buffer is advised as the first choice. A higher concentration of bicarbonate may be required in severe cases of acidosis. The use of a non-calcium-containing dialysate or replacement fluid is advised. The rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Regiocit will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 to 4 mmol/L. A BFR between 100 to 180 mL/min will be advised; a lower BFR can minimize patient citrate exposure, particularly in patients with lower body weight.
DRUG	Biphozyl	Biphozyl is used as a replacement fluid during CRRT. It is injected into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the filter. After the initiation of RRT, Biphozyl is used for late treatment of the acute condition when pH, potassium, and phosphate concentrations return to normal. Biphozyl can also be used if any other buffer is in use or during RCA. The volume and rate of administration of Biphozyl depend on the blood concentration of phosphate and other electrolytes, acid-base balance, body fluid balance, and overall clinical condition of the patient. The volume of replacement fluid given also depends on the expected intensity (dosage) of treatment.
DRUG	Prismasol 2	Prismasol 2 is used as a replacement fluid during CRRT. It is injected into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the filter. The volume and rate of administration of Prismasol 2 depend on the blood concentration of electrolytes, acid-base balance, fluid balance, and overall clinical condition of the patient. The volume of replacement fluid administered also depends on the required intensity (dosage) of the treatment.

Timeline

• Start date: 2024-10-23
• Primary completion: 2025-09-11
• Completion: 2025-09-11
• First posted: 2025-05-21
• Last updated: 2026-04-15

Locations

10 sites across 1 country: China