Clinical Scorecard: FDA clears integrated kidney replacement system

At a Glance

Key Highlights

• The FDA cleared multiFiltratePRO for CKRT with integrated regional citrate anticoagulation and approved sodium citrate (Cienby) and calcium chloride (Calrezdy) solutions for patients weighing at least 40 kg.
• The integrated system eliminates the need for separate external citrate and calcium infusion pumps.
• In the RICH trial, median filter lifespan was 46.5 hours with citrate and 26 hours with heparin.
• Ninety-day mortality was 51.2% with citrate and 53.6% with heparin; the difference was not statistically significant, and the early-terminated trial was underpowered to establish a mortality difference.
• The RICH trial findings concern regional citrate anticoagulation generally and do not demonstrate superior outcomes with the newly cleared integrated system.

Guideline-Based Recommendations

Diagnosis

Management

• According to the source, sodium citrate is approved for regional citrate anticoagulation; calcium chloride is approved for calcium replacement during continuous venovenous hemodialysis or continuous venovenous hemodiafiltration.
• According to the source, the Ci-Ca protocol automatically adjusts citrate and calcium infusion rates to changes in blood and effluent flow to maintain protocol-defined ratios.

Monitoring & Follow-up

• The source recommends monitoring ionized and total calcium concentrations, electrolytes, and acid-base status.
• The source recommends electrocardiography as clinically indicated.

Risks

• According to the source, sodium citrate risks include hypocalcemia, hypercalcemia, hypernatremia, hypomagnesemia, and acid-base disturbances.
• According to the source, sodium citrate may be contraindicated in patients with severely impaired citrate metabolism or known hypersensitivity; particular caution is advised with hepatic impairment or shock because of potential citrate accumulation.
• According to the source, calcium chloride replacement can cause calcium disturbances, cardiac arrhythmias, and hypotension.

Patient & Prescribing Data

The RICH trial randomized 596 critically ill patients with acute kidney injury to regional citrate or systemic heparin anticoagulation during CKRT. Median filter lifespan was longer with citrate (46.5 vs 26 hours). Ninety-day mortality was 51.2% with citrate and 53.6% with heparin; the difference was not statistically significant. The trial was terminated early and was underpowered to establish a mortality difference.

Clinical Best Practices

• Consider the stated risks and contraindications when using sodium citrate, with particular caution in hepatic impairment or shock.
• Monitor calcium, electrolytes, and acid-base status during treatment; obtain electrocardiography as clinically indicated.
• Do not interpret the RICH trial as evidence that the newly cleared integrated system improves outcomes over other approaches.

Related Resources & Content

• Fresenius Medical Care press release
• JAMA