Clinical trial NCT05758077: Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - a Randomized Clinical Trial in Acute Kidney Injury
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Keywords: continuous kidney replacement therapy
continuous renal replacement therapy
acute kidney injury
organ failure
inflammation
dialysis
acute tubular necrosis
Lead sponsor: SeaStar Medical
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Composite endpoint of mortality or dialysis dependency at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: MAKE90
timeFrame: 90 days
measure: Dialysis dependence
timeFrame: 1 year
measure: ICU free days in the first 28 days
timeFrame: 28 days
measure: Mortality at 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hospital
state: Alabama
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare
state: Arkansas
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital Anschutz Medical Campus
state: Colorado
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Augusta
country: United States
facility: JMS Burn Center
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky HealthCare
state: Kentucky
city: Shreveport
country: United States
facility: Ochsner LSU Health Academic Medical Center
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: UNLV Health
state: Nevada
city: Rochester
country: United States
facility: Unversity of Rochester
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Corvallis
country: United States
facility: Samaritan Health
state: Oregon
city: Bethlehem
country: United States
facility: St Luke's University Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Langhorne
country: United States
facility: Saint Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Nazareth Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: JBSA Fort Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital Metropolitan
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health San Antonio
state: Texas
city: Norfolk
country: United States
facility: Sentara Health
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
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