🔎 Trials Near Me

Home › Acute Kidney Injury › NCT05758077

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

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: SeaStar Medical · Participants: 339 · Started: Apr 17, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05758077

Locations in the U.S.

AlabamaUniversity of Alabama Birmingham Hospital, Birmingham
ArizonaMayo Clinic in Arizona, Phoenix (Not yet recruiting)
CaliforniaKeck Hospital of USC, Los Angeles (Not yet recruiting)
Ronald Reagan UCLA Medical Center, Los Angeles
Stanford University, Palo Alto
University of California San Francisco, San Francisco
FloridaMayo Clinic in Florida, Jacksonville (Not yet recruiting)
AdventHealth Orlando, Orlando
GeorgiaEmory Healthcare, Atlanta
Northeast Georgia Health System, Gainesville (Not yet recruiting)
IowaUniversity of Iowa Hospital, Iowa City
KentuckyUniversity of Kentucky HealthCare, Lexington (Not yet recruiting)
LouisianaOchsner LSU Health Academic Medical Center, Shreveport
MarylandUniversity of Maryland Medical Center, Baltimore (Not yet recruiting)
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Medical Center, Detroit
MinnesotaMayo Clinic, Rochester
New YorkThe Mount Sinai Hospital, New York (Not yet recruiting)
Stony Brook University Hospital, Stony Brook (Not yet recruiting)
North CarolinaUniversity of North Carolina, Chapel Hill (Not yet recruiting)
OhioUniversity of Cincinnati, Cincinnati
Cleveland Clinic, Cleveland
The Ohio State University Wexner Medical Center, Columbus (Not yet recruiting)
PennsylvaniaSt Luke's University Hospital, Bethlehem
Saint Mary Medical Center, Langhorne
South CarolinaMedical University of South Carolina, Charleston (Not yet recruiting)
TexasUniversity of Texas Southwestern Medical Center, Dallas
Brooke Army Medical Center, Fort Sam Houston
Methodist Hospital, San Antonio
Methodist Hospital Metropolitan, San Antonio
University of Texas Health San Antonio, San Antonio
VirginiaSentara Health, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.