Selective Cytopheretic Device for Acute Kidney Injury

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
339 (estimated)
Sponsor
SeaStar Medical · Industry
Who this trial is looking for

This trial is looking for patients with Acute Kidney Injury who are in the ICU and need continuous kidney treatment. Participants will receive additional treatment with a device to see if it helps improve survival and reduce the need for dialysis.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old but no older than 80.
  • I have Acute Kidney Injury stage 2 or greater.
  • I have been on continuous kidney replacement therapy for 12 to 48 hours.
  • I have another serious organ problem.
  • I have acceptable access for kidney treatment.
  • My C-Reactive Protein level is over 3.5 mg/dl.
  • I can commit to the current level of care for at least 96 hours.

You may not be able to join if

  • I am not expected to survive the next 24 hours.
  • I am transitioning to comfort care or hospice soon.
  • I have a terminal condition where I am not expected to survive 28 days.
  • I have advanced cancer that is actively being treated.
  • I have been in the ICU for more than 14 days during this hospital stay.
  • I have an active COVID-19 infection.
  • I have a history of chronic kidney disease stage greater than 3.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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