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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama Birmingham Hospital | Birmingham | Alabama | Recruiting |
| Mayo Clinic in Arizona | Phoenix | Arizona | Not Yet Recruiting |
| Keck Hospital of USC | Los Angeles | California | Not Yet Recruiting |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | Recruiting |
| Stanford University | Palo Alto | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| University of Colorado Hospital Anschutz Medical Campus | Aurora | Colorado | Withdrawn |
| Mayo Clinic in Florida | Jacksonville | Florida | Not Yet Recruiting |
| AdventHealth Orlando | Orlando | Florida | Recruiting |
| Emory Healthcare | Atlanta | Georgia | Recruiting |
| JMS Burn Center | Augusta | Georgia | Withdrawn |
| Northeast Georgia Health System | Gainesville | Georgia | Not Yet Recruiting |
| University of Iowa Hospital | Iowa City | Iowa | Recruiting |
| University of Kentucky HealthCare | Lexington | Kentucky | Not Yet Recruiting |
| Ochsner LSU Health Academic Medical Center | Shreveport | Louisiana | Recruiting |
| University of Maryland Medical Center | Baltimore | Maryland | Not Yet Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Henry Ford Medical Center | Detroit | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| The Mount Sinai Hospital | New York | New York | Not Yet Recruiting |
| Stony Brook University Hospital | Stony Brook | New York | Not Yet Recruiting |
| University of North Carolina | Chapel Hill | North Carolina | Not Yet Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | Not Yet Recruiting |
| Samaritan Health | Corvallis | Oregon | Active Not Recruiting |
| St Luke's University Hospital | Bethlehem | Pennsylvania | Recruiting |
| Saint Mary Medical Center | Langhorne | Pennsylvania | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Not Yet Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Brooke Army Medical Center | Fort Sam Houston | Texas | Recruiting |
| United States Army Institute of Surgical Research | JBSA Fort Sam Houston | Texas | Withdrawn |
| Methodist Hospital Metropolitan | San Antonio | Texas | Recruiting |
| Methodist Hospital | San Antonio | Texas | Recruiting |
| University of Texas Health San Antonio | San Antonio | Texas | Recruiting |
| Sentara Health | Norfolk | Virginia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05758077 on ClinicalTrials.gov ↗ ← All trials in the USA