Actively Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Led by SeaStar Medical · Updated on 2026-04-23
339
Participants Needed
38
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to an ICU requiring continuous kidney replacement therapy with Acute Kidney Injury stage 2 or greater at CKRT start
- On continuous kidney replacement therapy for at least 12 hours but no more than 48 hours at enrollment
- Between 18 and 80 years old at enrollment
- Have one additional life-threatening organ dysfunction
- Have acceptable vascular access for CKRT including adequate catheter size and length
- Committed to maintaining current level of care for at least 96 hours
- C-Reactive Protein level greater than 3.5 mg/dl
You will not qualify if you...
- Not expected to survive the next 24 hours
- Expected to transition to comfort measures or hospice within 4 days
- Terminal condition with expected survival less than 28 days or therapy considered futile
- Advanced malignancy actively treated or treated with palliative chemotherapy or radiation
- ICU stay longer than 14 days during current hospital admission
- Active COVID-19 infection as primary diagnosis
- Chronic use of ventricular assist devices
- End-stage renal disease requiring chronic kidney replacement therapy
- History of chronic kidney disease greater than Stage 3
- Acute Kidney Injury stage 0 or 1 at CKRT start
- Non-acute tubular necrosis Acute Kidney Injury diagnosis
- Recent acute coronary syndrome, stroke, or major vascular event within 48 hours
- Active bleeding requiring blood transfusions
- Acute on chronic liver failure
- Suspected hepato-renal syndrome
- Previous solid organ transplant
- Severe burns with modified Baux score over 100
- Bone marrow transplant within last year
- Chronic immunosuppression over 20 mg/day prednisone or similar steroids for past 30 days
- History of primary or secondary immune disorders including HIV or AIDS
- Dry weight over 150 kg
- Platelet count below 15,000/mm3
- Prisoner or member of vulnerable population
- Pregnant or breastfeeding
- Concurrent participation in another interventional trial
- Need for plasmapheresis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
6
University of Colorado Hospital Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Withdrawn
7
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
8
AdventHealth Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
9
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Withdrawn
10
Emory Healthcare
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
11
JMS Burn Center
Augusta, Georgia, United States, 30909
Withdrawn
12
Northeast Georgia Health System
Gainesville, Georgia, United States, 30501
Not Yet Recruiting
13
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
University of Kentucky HealthCare
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
15
Ochsner LSU Health Academic Medical Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
16
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
17
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Actively Recruiting
19
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
20
UNLV Health
Las Vegas, Nevada, United States, 89154
Not Yet Recruiting
21
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
22
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
23
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
25
Samaritan Health
Corvallis, Oregon, United States, 97330
Actively Recruiting
26
St Luke's University Hospital
Bethlehem, Pennsylvania, United States, 19015
Actively Recruiting
27
Saint Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Actively Recruiting
28
Nazareth Hospital
Philadelphia, Pennsylvania, United States, 19152
Not Yet Recruiting
29
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Not Yet Recruiting
30
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
31
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
32
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Actively Recruiting
33
United States Army Institute of Surgical Research
JBSA Fort Sam Houston, Texas, United States, 78234
Withdrawn
34
Methodist Hospital Metropolitan
San Antonio, Texas, United States, 78212
Actively Recruiting
35
Methodist Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
36
University of Texas Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
37
Sentara Health
Norfolk, Virginia, United States, 23507
Actively Recruiting
38
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Not Yet Recruiting
Research Team
M
Mohamed Zidan, MD
CONTACT
K
Kevin K Chung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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