The US Food and Drug Administration (FDA) has cleared Fresenius Medical Care's multiFiltratePRO system for continuous kidney replacement therapy (CKRT) with integrated regional citrate anticoagulation and approved 2 accompanying solutions for adults and pediatric patients weighing at least 40 kg, according to a Fresenius Medical Care press release.
The regulatory actions expand US access to an integrated approach for managing critically ill patients with acute kidney injury. The company described the system and accompanying solutions as the first integrated CKRT package in the US to support on-label regional citrate anticoagulation using its Ci-Ca protocol.
The FDA approved sodium citrate solution (Cienby) for regional citrate anticoagulation and calcium chloride solution (Calrezdy) for calcium replacement during continuous venovenous hemodialysis or continuous venovenous hemodiafiltration. The multiFiltratePRO system integrates citrate and calcium pumps, eliminating the need for separate external infusion pumps. Under the Ci-Ca protocol, infusion rates automatically adjust to changes in blood and effluent flow to maintain protocol-defined citrate and calcium ratios.
Regional citrate anticoagulation is intended to limit clotting within the extracorporeal circuit. In the multicenter randomized RICH trial, 596 critically ill patients with acute kidney injury received either regional citrate or systemic heparin anticoagulation during CKRT.
The trial assessed dialysis filter lifespan and 90-day all-cause mortality as coprimary end points. Median filter lifespan was 46.5 hours with citrate compared with 26 hours with heparin. Ninety-day mortality was 51.2% with citrate compared with 53.6% with heparin, a difference that was not statistically significant. The trial was terminated early and was underpowered to establish a mortality difference.
The findings support regional citrate anticoagulation generally, rather than demonstrating superior outcomes with the newly cleared integrated system.
According to the company’s press release, sodium citrate carries risks of hypocalcemia, hypercalcemia, hypernatremia, hypomagnesemia, and acid-base disturbances. They noted that the solution may be contraindicated in patients with severely impaired citrate metabolism or known hypersensitivity and advised particular caution in patients with hepatic impairment or shock because of the potential for citrate accumulation.
Calcium chloride replacement can cause calcium disturbances, cardiac arrhythmias, and hypotension. Recommended monitoring includes ionized and total calcium concentrations, electrolytes, acid-base status, and electrocardiography as clinically indicated.
Fresenius said the US launch will begin with a controlled rollout before broader availability. The company has not specified when full commercial distribution will begin.
Sources: Fresenius Medical Care, JAMA
