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RECRUITING
NCT06983509

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

Sponsor: Vantive Health LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2024-09-23

Completion Date

2025-08-31

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

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.

Locations (10)

Beijing Chao-yang Hospital, Capital Medical University

Beijing, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Xuanwu Hospital Capital Medical University

Beijing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First People's Hospital of Guangzhou

Guangzhou, China

Zhujiang Hospital, Southern Medical University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

ZhongShan Hospital Fudan University

Shanghai, China

Shanghai East Hospital

Shanghai, China

Zhongnan Hospital, Wuhan University

Wuhan, China