🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05758077
Recruiting Not applicable

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

NCT05758077 · tracked via the Priya Life Science USA tracker
Sponsor
SeaStar Medical
Phase
Not applicable
Started
2023-04-17
Last updated
2026-09-10

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

Selective Cytopheretic DeviceStandard of Care

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
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

More SeaStar Medical trials in the USA

Other trials for the same condition

Official registry record

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