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
Study Type
OBSERVATIONAL
Enrollment
300
QUELIMMUNE device used as part of clinical practice.
Children's of Alabama
Birmingham, Alabama, United States
RECRUITINGLucile Packard Children's Hospital Stanford
Palo Alto, California, United States
RECRUITINGUCSF Benioff Children's
San Francisco, California, United States
RECRUITINGChildren's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, United States
NOT_YET_RECRUITINGChildren's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, United States
NOT_YET_RECRUITINGLurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGCS Mott Children's Hospital
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital
Cincinnati, Ohio, United States
RECRUITINGCleveland Clinic Children's Hospital
Cleveland, Ohio, United States
NOT_YET_RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITING...and 3 more locations
Safety
New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner
Time frame: 28 days or through hospital discharge, whichever is sooner
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