๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-20

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury (NCT05758077)

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

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: SeaStar Medical

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama Birmingham Hospital โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • University of Alabama Birmingham Hospital โ€” Birmingham, Alabama
  • Mayo Clinic in Arizona โ€” Phoenix, Arizona
  • Ronald Reagan UCLA Medical Center โ€” Los Angeles, California
  • Stanford University โ€” Palo Alto, California
  • University of California San Francisco โ€” San Francisco, California
  • University of Colorado Hospital Anschutz Medical Campus โ€” Aurora, Colorado
  • Mayo Clinic in Florida โ€” Jacksonville, Florida
  • AdventHealth Orlando โ€” Orlando, Florida
  • Orlando Regional Medical Center โ€” Orlando, Florida
  • Emory Healthcare โ€” Atlanta, Georgia
  • JMS Burn Center โ€” Augusta, Georgia
  • Northeast Georgia Health System โ€” Gainesville, Georgia
  • University of Iowa Hospital โ€” Iowa City, Iowa
  • University of Kentucky HealthCare โ€” Lexington, Kentucky
  • Ochsner LSU Health Academic Medical Center โ€” Shreveport, Louisiana
  • University of Maryland Medical Center โ€” Baltimore, Maryland
  • University of Michigan โ€” Ann Arbor, Michigan
  • Henry Ford Medical Center โ€” Detroit, Michigan
  • Mayo Clinic โ€” Rochester, Minnesota
  • UNLV Health โ€” Las Vegas, Nevada
  • University of North Carolina โ€” Chapel Hill, North Carolina
  • University of Cincinnati โ€” Cincinnati, Ohio
  • Cleveland Clinic โ€” Cleveland, Ohio
  • The Ohio State University Wexner Medical Center โ€” Columbus, Ohio
  • Samaritan Health โ€” Corvallis, Oregon

๐Ÿ“ž Contact the Study Coordinator

Phone: (844) 427-8100

Email: mzidan@seastarmed.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—