Baxter International has obtained the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for Regiocit, a replacement solution for patients suffering from acute kidney injury (AKI).
The FDA authorisation allows Regiocit to be used as a replacement solution in adult patients under continuous renal replacement therapy (CRRT), for whom regional citrate anticoagulation is applicable during the Covid-19 pandemic.
The company said that its replacement solution Regiocit comprises citrate and is said to facilitate regional citrate anticoagulation of the extracorporeal circuit.
Baxter Acute Therapies business general manager Reaz Rasul said: “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 US optimize care for critically ill patients requiring CRRT and regional citrate anticoagulation, while bringing an additional supply of replacement solutions to the US.
Regiocit is used for regional citrate anticoagulation in patients undergoing CRRT
Acute kidney injury (AKI) is a potentially dangerous condition characterised by the kidneys abruptly stop working and accumulation if fluid and uremic toxins in the body, and is affecting patients suffering from Covid-19.
CRRT is a therapeutic procedure that mostly resembles the functions of natural kidneys and works by passing hemodynamically unstable patient’s blood through an extracorporeal filter, where fluid and uremic toxins are removed and the cleaned blood is returned to the body.
CRRT needs replacement fluids to flush toxins from the body and replace electrolytes and volume lost during the filtration process.
An increased rate of filter clotting during CRRT has been reported in Covid-19 patients as a result from cytokine storms, when high levels of inflammatory mediators circulate in the blood.
An anticoagulant is infused into the blood circuit to prevent clotting during the procedure, as clotting disrupts the blood flow and affects the treatment
Baxter said that citrate-based replacement solution eliminates the need for blood thinners, and is used for regional citrate anticoagulation in patients who are at greater risk of bleeding during CRRT.
According to the company, Regiocit is the only FDA authorised citrate-based replacement solution for use in CRRT during the Covid-19 pandemic. It contains 140mmol/l Sodium, 86mmol/l Chloride, low concentration of citrate.
Regiocit provides necessary pre-filter volumes required to replace filtration losses during convective therapies, and can be used in along with other standard dialysis and replacement solutions to supplement the missing electrolytes including potassium, magnesium and phosphate.
Furthermore, Regiocit is authorised only for use during the Covid-19 pandemic, but has not been approved by the FDA. The solution is intended for use in continuous venovenous hemofiltration (CVVH) and hemodiafiltration (CVVHDF) modalities.
