Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - a Randomized Clinical Trial in Acute Kidney Injury
- Conditions
- Acute Kidney Injury
- Interventions
- Other: Standard of CareDevice: Selective Cytopheretic Device
- Registration Number
- NCT05758077
- Lead Sponsor
- SeaStar Medical
- Brief 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 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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Admitted to an ICU requiring CKRT:
- Must have AKI stage 2 or greater at the time of CKRT initiation.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKRT Alone Arm (standard of care) Standard of Care This arm will receive standard of care CKRT therapy for their condition as appropriate. SCD + CKRT Arm Selective Cytopheretic Device In addition to standard of care CKRT therapy for these subjects, these subjects will have up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) in-line with their existing CKRT circuit.
- Primary Outcome Measures
Name Time Method Composite endpoint of mortality or dialysis dependency at 90 days 90 days The composite of death or requiring kidney replacement therapy at 90 days post randomization
- Secondary Outcome Measures
Name Time Method Dialysis dependence 1 year Need for any form of kidney replacement therapy at one year
MAKE90 90 days Major adverse kidney events at day 90 is a composite of death, need for KRT, or persistent renal dysfunction (final serum creatinine concentration, ≥200% of the baseline value) at the 90 day follow up period
Mortality at 28 days 28 days Death by day 28 post randomization
ICU free days in the first 28 days 28 days The number of days alive and requiring ICU level of care in the 28 days after randomization for at least 24 hours
Trial Locations
- Locations (30)
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
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 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
Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Saint Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Nazareth Hospital
🇺🇸Philadelphia, Pennsylvania, 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