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NCT05758077NARecruiting

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

SeaStar Medical

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

Inclusion Criteria: * Admitted to an ICU requiring CKRT: 1. Must have AKI stage 2 or greater at the time of CKRT initiation. 2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment. * At least 18 years of age but not older than 80 at the time of enrollment. * One additional life-threatening organ dysfunction present. * Acceptable vascular access for CKRT to include adequate lumen size and length of catheters. * Initial (non-binding) commitment to maintaining current level of care for at least 96 hours. * C-Reactive Protein \>3.5 mg/dl. Exclusion Criteria: * Not expected to survive next 24 hours. * Anticipated transition to comfort measures or hospice in next 4 days. * Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI. * Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation. * ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening. * Active COVID-19 infection with a primary admission diagnosis of COVID-19. * Chronic use of ventricular assist devices. * ESRD requiring chronic kidney replacement therapy. * History of CKD (greater than Stage 3). * AKI stage 0 or stage 1 at the time of CKRT initiation. * Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial. * Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization. * Active hemorrhage requiring blood transfusions at the time of screening. * Acute on Chronic Liver Failure. * Suspicion of hepato-renal syndrome. * Presence of any solid organ transplant at any time prior to admission. * Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury). * Bone marrow transplant within the last year. * Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission. * Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS. * Dry weight of \>150kg. * Platelet count \<15,000/mm3. * Patient is a prisoner or member of a vulnerable population. * Patient is pregnant or breast feeding. * Concurrent enrollment in another interventional clinical trial for an investigational drug or device. * Need for plasmapheresis.

Interventions

DEVICE

Selective Cytopheretic Device

OTHER

Standard of Care

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Conditions

Acute Kidney Injury

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