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.
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