A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

What this Trial Is About

Researchers are evaluating whether adding up to ten sequential 24-hour treatments using the Selective Cytopheretic Device (SCD) to continuous kidney replacement therapy (CKRT) can improve survival and reduce the need for long-term dialysis in patients with Acute Kidney Injury (AKI) who require CKRT. This pivotal, randomized, controlled study involves approximately 339 patients in intensive care units across multiple sites. The study aims to compare outcomes between patients receiving standard CKRT care alone and those receiving CKRT plus SCD treatments. Participants in the experimental group will receive standard CKRT plus up to ten consecutive 24-hour sessions with the SCD integrated into their existing CKRT circuit. The SCD device, which includes a synthetic hollow fiber membrane cartridge connected in series with the CKRT hemofilter, is designed to modulate inflammation by binding activated white blood cells during treatment. Regional citrate anticoagulation will be used throughout the blood circuit. The control group will receive standard CKRT therapy alone as appropriate. Treatments will be monitored over time to assess safety and efficacy. Throughout the study, patients will be closely monitored using clinical assessments and laboratory tests. The primary outcome is a combined measure of mortality or dialysis dependency at 90 days after treatment. Secondary outcomes include dialysis dependence at one year, ICU-free days within the first 28 days, and mortality at 28 days. Patient safety will be observed continuously, and the total study participation may extend over several months to evaluate long-term effects of the therapies.

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury