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Abstract: INFO05-SA

NEUTRALIZE-AKI: A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with AKI Requiring Continuous Kidney Replacement Therapy (CKRT)

Session Information

  • Informational Posters - III
    November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

  • No subcategory defined

Authors

  • Yessayan, Lenar Tatios, University of Michigan, Ann Arbor, Michigan, United States
  • Humes, H. David, University of Michigan, Ann Arbor, Michigan, United States
  • Iyer, Sai Prasad N., SeaStar Medical, Denver, Colorado, United States
  • Scribe, Emily, SeaStar Medical, Denver, Colorado, United States
  • Chung, Kevin K., SeaStar Medical, Denver, Colorado, United States
Description

Acute Kidney Injury (AKI) is lethal in critically ill patients, with ICU mortality rates of 50-80%, indicating a need for better treatment options for these patients. AKI promotes a systemic inflammatory response which results in systemic microvascular damage and, if severe, multi-organ dysfunction. Activated effector cells, notably neutrophils and monocytes, play a central role in this process. The selective cytopheretic device (SCD), a novel cell-directed extracorporeal therapy, targets and deactivates these cells without immunosuppression. The NEUTRALIZE-AKI study aims to evaluate the safety and efficacy of the SCD in adults with AKI requiring continuous kidney replacement therapy (CKRT). This is a two-arm, randomized, open-label, controlled multi-center pivotal US study which will enroll 200 adult patients (age 18-80 years) in the ICU with AKI requiring CKRT and at least one additional organ failure. Eligible patients will be randomized to CKRT plus SCD therapy versus CKRT alone, with therapy for up to 10 days. The primary outcome is a composite of dialysis dependence or all-cause mortality at day 90. Key secondary endpoints include major adverse kidney events at day 90, dialysis dependence at one year, ICU-free days in the first 28 days, and mortality at day 28. Exploratory endpoints include mortality of ARDS & sepsis subgroups at day 28, QoL, ICU & hospital readmissions, and mortality at 1 year.

SCD in CKRT Circuit

NEUTRALIZE-AKI Study Design

Funding

  • SeaStar Medical