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

Recruiting N/A Interventional Study
Acute Kidney Injury
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
339 (estimated)
Sponsor
SeaStar Medical · Industry
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About This Trial
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 re…
Trial Locations
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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 e…
Contacts

Mohamed Zidan, MD

844-427-8100

mzidan@seastarmed.com

CONTACT

Kevin K Chung, MD

844-427-8100

kchung@seastarmed.com

CONTACT