Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Start Date
4/17/2023
Completion Date
6/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Selective Cytopheretic Device
Standard of Care
Conditions
Locations
University of Alabama Birmingham Hospital
Birmingham, Alabama 35233
United States
Mayo Clinic in Arizona
Phoenix, Arizona 85054
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Stanford University
Palo Alto, California 94304
United States
University of California San Francisco
San Francisco, California 94143
United States
University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado 80045
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
Orlando Regional Medical Center
Orlando, Florida 32806
United States
Emory Healthcare
Atlanta, Georgia 30322
United States
JMS Burn Center
Augusta, Georgia 30909
United States
Northeast Georgia Health System
Gainesville, Georgia 30501
United States
University of Iowa Hospital
Iowa City, Iowa 52242
United States
University of Kentucky HealthCare
Lexington, Kentucky 40536
United States
Ochsner LSU Health Academic Medical Center
Shreveport, Louisiana 71103
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Henry Ford Medical Center
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55902
United States
UNLV Health
Las Vegas, Nevada 89154
United States
University of North Carolina
Chapel Hill, North Carolina 27599
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Samaritan Health
Corvallis, Oregon 97330
United States
St Luke's University Hospital
Bethlehem, Pennsylvania 19015
United States
Saint Mary Medical Center
Langhorne, Pennsylvania 19047
United States
Nazareth Hospital
Philadelphia, Pennsylvania 19152
United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18711
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Brooke Army Medical Center
Fort Sam Houston, Texas 78234
United States
United States Army Institute of Surgical Research
JBSA Fort Sam Houston, Texas 78234
United States
Methodist Hospital Metropolitan
San Antonio, Texas 78212
United States
Methodist Hospital
San Antonio, Texas 78229
United States
University of Texas Health San Antonio
San Antonio, Texas 78229
United States
Sentara Health
Norfolk, Virginia 23507
United States
Virginia Commonwealth University
Richmond, Virginia 23219
United States