QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
SeaStar Medical
300 participants
Jul 19, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria1
- All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
Exclusion Criteria3
- Weight \<10kg
- Age \>22 years
- Known allergy to any components of QUELIMMUNE
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Interventions
QUELIMMUNE device used as part of clinical practice.
Locations(15)
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NCT06517810