Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT05758077 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • OTHER Standard of Care
  • DEVICE Selective Cytopheretic Device

Study Locations (20)

California

  • Ronald Reagan UCLA Medical Center — Los Angeles
  • Stanford University — Palo Alto

Florida

  • AdventHealth Orlando — Orlando
  • Orlando Regional Medical Center — Orlando

Michigan

  • University of Michigan — Ann Arbor
  • Henry Ford Medical Center — Detroit

Ohio

  • University of Cincinnati — Cincinnati
  • Cleveland Clinic — Cleveland

Alabama

  • University of Alabama Birmingham Hospital — Birmingham

Arkansas

  • Central Arkansas Veterans Healthcare — Little Rock

Colorado

  • University of Colorado Hospital Anschutz Medical Campus — Aurora

Georgia

  • JMS Burn Center — Augusta

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2023-04-17
Est. Completion 2027-06
Phase NA

Sponsor

SeaStar Medical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05758077

The ClinicalTrials.gov registry entry for NCT05758077 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SeaStar Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05758077 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05758077 about?

NCT05758077 is a clinical study titled "Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury". 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 CK...

What is the current status of trial NCT05758077?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-04-17. Estimated completion is 2027-06.

What conditions does trial NCT05758077 study?

This clinical trial studies the following conditions: Acute Kidney Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05758077?

The interventions under investigation include: Standard of Care (OTHER), Selective Cytopheretic Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05758077?

This trial is sponsored by SeaStar Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05758077 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial