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RECRUITING
NCT05758077
NA

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

Sponsor: SeaStar Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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