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

RecruitingOBSERVATIONAL
Enrollment

220

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Renal Insufficiency
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."

Trial Locations (10)

100020

RECRUITING

Beijing Chao-yang Hospital, Capital Medical University, Beijing

100029

RECRUITING

Beijing Anzhen Hospital, Capital Medical University, Beijing

100053

RECRUITING

Xuanwu Hospital Capital Medical University, Beijing

200032

RECRUITING

ZhongShan Hospital Fudan University, Shanghai

200120

RECRUITING

Shanghai East Hospital, Shanghai

310014

RECRUITING

Zhejiang Provincial People's Hospital, Hangzhou

400016

RECRUITING

The First Affiliated Hospital of Chongqing Medical University, Chongqing

430071

RECRUITING

Zhongnan Hospital, Wuhan University, Wuhan

510180

RECRUITING

The First People's Hospital of Guangzhou, Guangzhou

510280

RECRUITING

Zhujiang Hospital, Southern Medical University, Guangzhou

All Listed Sponsors
lead

Vantive Health LLC

INDUSTRY