Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
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
Stručný súhrn
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Základné údaje
| Ochorenia | Acute Kidney Injury |
|---|---|
| Intervencie |
DEVICE: Selective Cytopheretic Device OTHER: Standard of Care |
| Sponzor | SeaStar Medical |
| Plánovaný počet | 339 |
| Začiatok | 2023-04-17 |
| Predp. ukončenie (primárne) | 2026-12-01 |
| Krajiny | United States |
| Posledná aktualizácia | 2026-04-23 |