$SeaStar Medical (ICU.US)$The NEuTRALIZE-AKI trial, with a planned enrollment of 200 subjects, will be the largest pivotal trial to date assessing the safety and efficacy of the SCD, with the aim of reducing mortality and dialysis dependence in adult patients with AKI and multiorgan dysfunction requiring CRRT. It was designed in part based on key lessons learned from past studies. First, the protocol mandates strict adherence by clinical sites tomaintaining circuit iCa levels below 0.4mmol/L, as it is within this range that highly activated white blood cells, specifically neutrophils and monocytes, are immunomodulated by the SCD to less inflammatory states [29]. Second, sites are required to commit non-bindingly to using the SCD for at least 96h to ensure that the patient receives the maximum clinical benefit from the continuous leukocyte immunomod- ulation provided by the SCD [29]. Third, dialysis dependence is included as a component of the primary study endpoint, which is a composite of mortality and dialysis dependence assessed 90 days post-randomization. There is compelling evi- dence from previous studies that the SCD promotes organ recovery, and this effect may persist well beyond the ICu stay [19–24]. Fourth, C-reactive protein (CRP) is used as a marker to screen out potentially ‘hypoinflammatory’ subtypes of patients who may have lower chances of responding to therapy with the SCD. Eligible subjects must have CRP levels of at least 3.5mg/dL.
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