RecruitingNCT06983509

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

Sponsor

Vantive Health LLC

Enrollment

220 participants

Start Date

Sep 23, 2024

Study Type

OBSERVATIONAL

Conditions

Renal Insufficiency

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

≤ 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 Criteria5

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.

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Interventions

DRUGRegiocit

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.

DRUGBiphozyl

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.

DRUGPrismasol 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.