RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 200 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

Quick Facts

Study Start:2023-04-17
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05758077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Admitted to an ICU requiring CKRT:
  2. 1. Must have AKI stage 2 or greater at the time of CKRT initiation.
  3. 2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
  4. * At least 18 years of age but not older than 80 at the time of enrollment.
  5. * One additional life-threatening organ dysfunction present.
  6. * Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.
  7. * Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.
  8. * C-Reactive Protein \>3.5 mg/dl.
  1. * Not expected to survive next 24 hours.
  2. * Anticipated transition to comfort measures or hospice in next 4 days.
  3. * 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.
  4. * Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
  5. * ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
  6. * Active COVID-19 infection with a primary admission diagnosis of COVID-19.
  7. * Chronic use of ventricular assist devices.
  8. * ESRD requiring chronic kidney replacement therapy.
  9. * History of CKD (greater than Stage 3).
  10. * AKI stage 0 or stage 1 at the time of CKRT initiation.
  11. * 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.
  12. * Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
  13. * Active hemorrhage requiring blood transfusions at the time of screening.
  14. * Acute on Chronic Liver Failure.
  15. * Suspicion of hepato-renal syndrome.
  16. * Presence of any solid organ transplant at any time prior to admission.
  17. * Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury).
  18. * Bone marrow transplant within the last year.
  19. * 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.
  20. * Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
  21. * Dry weight of \>150kg.
  22. * Platelet count \<15,000/mm3.
  23. * Patient is a prisoner or member of a vulnerable population.
  24. * Patient is pregnant or breast feeding.
  25. * Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
  26. * Need for plasmapheresis.

Contacts and Locations

Study Contact

Mohamed Zidan, MD
CONTACT
844-427-8100
mzidan@seastarmed.com
Kevin K Chung, MD
CONTACT
844-427-8100
kchung@seastarmed.com

Study Locations (Sites)

University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
United States
Central Arkansas Veterans Healthcare
Little Rock, Arkansas, 72205
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
Stanford University
Palo Alto, California, 94304
United States
University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Orlando Regional Medical Center
Orlando, Florida, 32806
United States
JMS Burn Center
Augusta, Georgia, 30909
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 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
Unversity of Rochester
Rochester, New York, 14627
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Samaritan Health
Corvallis, Oregon, 97330
United States
St Luke's University Hospital
Bethlehem, Pennsylvania, 19015
United States
Geisinger Health
Danville, Pennsylvania, 17822
United States
Saint Mary Medical Center
Langhorne, Pennsylvania, 19047
United States
Nazareth Hospital
Philadelphia, Pennsylvania, 19152
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
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

Collaborators and Investigators

Sponsor: SeaStar Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • continuous kidney replacement therapy
  • continuous renal replacement therapy
  • acute kidney injury
  • organ failure
  • inflammation
  • dialysis
  • acute tubular necrosis

Additional Relevant MeSH Terms

  • Acute Kidney Injury