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NCT05758077 · ClinicalTrials.gov registry record · NA

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

A NA study of Acute Kidney Injury, sponsored by SeaStar Medical.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
20
Study locations

NCT05758077 is a NA study of Acute Kidney Injury that is actively recruiting participants, run by SeaStar Medical. The registered enrollment target is 200 participants, below the 2,328-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05758077, a NA study of Acute Kidney Injury, is actively recruiting participants, sponsored by SeaStar Medical.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
20
Study locations

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

6 total trials

What the Registry Record Tells You About NCT05758077

The ClinicalTrials.gov registry entry for NCT05758077 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,328-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (91% lower). The listed sponsor is SeaStar Medical, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05758077 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, Michigan.

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.

What interventions are being tested in trial NCT05758077?

The interventions under investigation include: Standard of Care (OTHER), Selective Cytopheretic Device (DEVICE).

Who is sponsoring clinical trial NCT05758077?

This trial is sponsored by SeaStar Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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

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