Condition: Acute Kidney Injury · Acute Kidney Injury Due to Sepsis · Sponsor: SeaStar Medical
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
This description comes directly from the study's public registry record.
Mohamed Zidan, MD · 844-427-8100 · mzidan@seastarmed.com
Kevin K Chung, MD · 844-427-8100 · kchung@seastarmed.com
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| Children's of Alabama | Birmingham, Alabama, United States | Recruiting |
| Lucile Packard Children's Hospital Stanford | Palo Alto, California, United States | Recruiting |
| UCSF Benioff Children's | San Francisco, California, United States | Recruiting |
| HealthONE HCA Rocky Mountain Children's Hospital | Denver, Colorado, United States | Recruiting |
| Children's Hospital of Atlanta - Arthur M. Blank | Atlanta, Georgia, United States | Recruiting |
| Children's Hospital of Atlanta - Scottish Rite | Atlanta, Georgia, United States | Recruiting |
| Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| CS Mott Children's Hospital | Ann Arbor, Michigan, United States | Recruiting |
| Cincinnati Children's Hospital | Cincinnati, Ohio, United States | Recruiting |
| Cleveland Clinic Children's Hospital | Cleveland, Ohio, United States | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
| Monroe Carrell Jr Children's Hospital at Vanderbilt | Nashville, Tennessee, United States | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06517810