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

ClinicalTrials.gov ID: NCT05758077

Public ClinicalTrials.gov record NCT05758077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05758077
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: SeaStar Medical; Industry
Enrollment: 339 participants

Conditions and interventions

Conditions

Acute Kidney Injury

Interventions

Selective Cytopheretic Device Device
Standard of Care Other

Device · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 17, 2023 (Actual)
Primary completion: Dec 2026 (Estimated)
Completion: Jun 2027 (Estimated)
Last update posted: Sep 10, 2026

2023 – 2027

United States locations

U.S. sites: 36
U.S. states: 20
U.S. cities: 33

Facility	City	State	ZIP	Site status
University of Alabama Birmingham Hospital	Birmingham	Alabama	35233	Recruiting
Mayo Clinic in Arizona	Phoenix	Arizona	85054	Not yet recruiting
Keck Hospital of USC	Los Angeles	California	90033	Not yet recruiting
Ronald Reagan UCLA Medical Center	Los Angeles	California	90095	Recruiting
Stanford University	Palo Alto	California	94304	Recruiting
University of California San Francisco	San Francisco	California	94143	Recruiting
University of Colorado Hospital Anschutz Medical Campus	Aurora	Colorado	80045	Withdrawn
Mayo Clinic in Florida	Jacksonville	Florida	32224	Not yet recruiting
AdventHealth Orlando	Orlando	Florida	32803	Recruiting
Emory Healthcare	Atlanta	Georgia	30322	Recruiting
JMS Burn Center	Augusta	Georgia	30909	Withdrawn
Northeast Georgia Health System	Gainesville	Georgia	30501	Not yet recruiting
University of Iowa Hospital	Iowa City	Iowa	52242	Recruiting
University of Kentucky HealthCare	Lexington	Kentucky	40536	Not yet recruiting
Ochsner LSU Health Academic Medical Center	Shreveport	Louisiana	71103	Recruiting
University of Maryland Medical Center	Baltimore	Maryland	21201	Not yet recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Henry Ford Medical Center	Detroit	Michigan	48202	Recruiting
Mayo Clinic	Rochester	Minnesota	55902	Recruiting
The Mount Sinai Hospital	New York	New York	10029	Not yet recruiting
Stony Brook University Hospital	Stony Brook	New York	11794	Not yet recruiting
University of North Carolina	Chapel Hill	North Carolina	27599	Not yet recruiting
University of Cincinnati	Cincinnati	Ohio	45219	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Not yet recruiting
Samaritan Health	Corvallis	Oregon	97330	Active, not recruiting
St Luke's University Hospital	Bethlehem	Pennsylvania	19015	Recruiting
Saint Mary Medical Center	Langhorne	Pennsylvania	19047	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29425	Not yet recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	75390	Recruiting
Brooke Army Medical Center	Fort Sam Houston	Texas	78234	Recruiting
United States Army Institute of Surgical Research	JBSA Fort Sam Houston	Texas	78234	Withdrawn
Methodist Hospital Metropolitan	San Antonio	Texas	78212	Recruiting
Methodist Hospital	San Antonio	Texas	78229	Recruiting
University of Texas Health San Antonio	San Antonio	Texas	78229	Recruiting
Sentara Health	Norfolk	Virginia	23507	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05758077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 10, 2026 · Synced Oct 21, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT05758077 live on ClinicalTrials.gov.

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