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 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Acute Kidney Injury
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 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - a Randomized Clinical Trial in Acute Kidney Injury
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University of Alabama Birmingham Hospital, Birmingham, Alabama, United States, 35233
Central Arkansas Veterans Healthcare, Little Rock, Arkansas, United States, 72205
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095
Stanford University, Palo Alto, California, United States, 94304
University of Colorado Hospital Anschutz Medical Campus, Aurora, Colorado, United States, 80045
Orlando Regional Medical Center, Orlando, Florida, United States, 32806
JMS Burn Center, Augusta, Georgia, United States, 30909
University of Iowa Hospital, Iowa City, Iowa, United States, 52242
University of Kentucky HealthCare, Lexington, Kentucky, United States, 40536
Ochsner LSU Health Academic Medical Center, Shreveport, Louisiana, United States, 71103
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
SeaStar Medical,
2026-09