Baxter Obtains U.S. FDA Emergency Use Authorization for Regiocit Replacement Solution Used in CRRT

Acute kidney injury (AKI), a potentially life-threatening condition where the kidneys suddenly stop working and fluid and uremic toxins build up in the body, is one of many complications affecting COVID-19 patients. A recent meta-analysis of 20 studies evaluated more than 13,000 hospitalized COVID-19 patients, 43% of whom were in the intensive care unit or had severe infection, and found that AKI prevalence was 17%, with a range of 0.5% - 80.3%.¹ CRRT mimics many of the functions of the natural kidney and is the cornerstone of treatment in patients

with severe AKI.² A citrate-based replacement solution can be used for regional citrate anticoagulation in patients who are at greater risk of bleeding during CRRT, as it eliminates the need to administer a blood thinner, such as Heparin, to prevent clotting in the circuit. Regiocit is the only authorized citrate-based replacement solution available in the U.S. for use in CRRT during the COVID-19 pandemic.

“Demand for CRRT remains elevated as the COVID-19 pandemic continues to progress, and we’re proud to offer Regiocit as an important new option to help healthcare providers in the U.S. optimize care for critically ill patients requiring CRRT and regional citrate anticoagulation, while bringing an additional supply of replacement solutions to the U.S.,” said Reaz Rasul, general manager of Baxter’s Acute Therapies business.

During CRRT, the patient's blood passes through an extracorporeal filter where fluid and uremic toxins are removed before the cleaned blood is returned to the body. CRRT allows for slow and continuous removal of fluid and toxins, which can be better tolerated than other conventional treatments in patients who are hemodynamically unstable. Replacement fluids are needed during CRRT to flush toxins from the body and replace electrolytes and volume lost during the filtration