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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: Recruiting NA study of Acute Kidney Injury, sponsored by SeaStar Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The composite of death or requiring kidney replacement therapy at 90 days post randomization
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05758077 shows while recruiting
NCT05758077 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,328-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (91% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
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Where NCT05758077's enrollment target sits among peer trials
200 33rd of 74 higher than 42 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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