QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Condition(s) studied

Investigational drug(s) / intervention(s)

QUELIMMUNE (SCD-PED): QUELIMMUNE device used as part of clinical practice.

Study summary

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

Eligibility

Primary outcome measure(s)

• Safety — 28 days or through hospital discharge, whichever is sooner
  New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner

Trial sites (15)

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