Baxter International has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Regiocit replacement solution.
The approval enables Regiocit to be used as a replacement solution only in adult patients being treated with continuous renal replacement therapy (CRRT) in patients, requiring regional citrate anticoagulation during the Covid-19 pandemic.
Acute kidney injury (AKI) is one of the many complications, affecting Covid-19 patients. It is a potentially life-threatening condition, in which the kidneys suddenly stop working and fluid and uremic toxins build up in the body.
CRRT, which is considered vital in the treatment of patients with severe AKI, serves many of the functions of the natural kidney.
Regiocit is considered to be the only authorised citrate-based replacement solution available in the US for use in CRRT during the Covid-19 pandemic.
Baxter Acute Therapies business general manager Reaz Rasul said: “Demand for CRRT remains elevated as the Covid-19 pandemic continues to progress, and we are proud to offer Regiocit as an important new option to help healthcare providers in the US optimise care for critically ill patients, requiring CRRT and regional citrate anticoagulation, while bringing an additional supply of replacement solutions to the US.”
During CRRT, replacement fluids are needed to flush toxins from the body and replace electrolytes and volume lost during the filtration process.
Covid-19 patients are prone to increased filter clotting during CRRT. This may be because of the cytokine storms that happen in some patients when high levels of inflammatory mediators circulate in the blood as an intense immune reaction to the virus.
Regiocitis consists of physiological concentrations of sodium, chloride and a low concentration of citrate. During convective therapies, it offers the necessary pre-filter volumes needed to replace filtration losses.
Additionally, it is used in combination with other standard dialysis and replacement solutions that supplement missing electrolytes such as potassium, magnesium and phosphate.