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Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Sponsor: SeaStar Medical
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
339
Start Date
2023-04-17
Completion Date
2027-06
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Selective Cytopheretic Device
The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic hollow fiber membrane cartridge. The device is connected in series to a commercially available CKRT hemofilter. Blood from the CKRT circuit is diverted after the CKRT hemofilter through to the extracapillary space (ECS) of the SCD cartridge. Blood circulates through the SCD ECS and then it is returned to the patient via the venous return line of the CKRT circuit. Regional citrate anticoagulation is used for the entire CKRT and SCD blood circuit. The SCD cartridge incorporates a synthetic hollow fiber membrane with the ability to bind activated leukocytes to its extracapillary surface; and when used in a CKRT extracorporeal circuit in the presence of regional citrate anticoagulation, the SCD modulates inflammation.
Standard of Care
Standard of care CKRT for the subject's condition, as appropriate
Locations (33)
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
Central Arkansas Veterans Healthcare
Little Rock, Arkansas, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado, United States
AdventHealth Orlando
Orlando, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
JMS Burn Center
Augusta, Georgia, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Kentucky HealthCare
Lexington, Kentucky, United States
Ochsner LSU Health Academic Medical Center
Shreveport, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
UNLV Health
Las Vegas, Nevada, United States
Unversity of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Samaritan Health
Corvallis, Oregon, United States
St Luke's University Hospital
Bethlehem, Pennsylvania, United States
Saint Mary Medical Center
Langhorne, Pennsylvania, United States
Nazareth Hospital
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
United States Army Institute of Surgical Research
JBSA Fort Sam Houston, Texas, United States
Methodist Hospital Metropolitan
San Antonio, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Texas Health San Antonio
San Antonio, Texas, United States
Sentara Health
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States