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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
Who can join
Up to age 22 · All sexes
Full eligibility criteria
Inclusion Criteria: * All patients initiated on QUELIMMUNE therapy under the HDE-approved indication Exclusion Criteria: * Weight \<10kg * Age \>22 years * Known allergy to any components of QUELIMMUNE
About the study
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
What is being tested
- QUELIMMUNE (SCD-PED) (device)
Sponsor: SeaStar Medical · Participants: 50 · Started: Jul 19, 2024
Contact the study team
- Mohamed Zidan, MD · Phone: 844-427-8100
- Kevin K Chung, MD · Phone: 844-427-8100
Official record on ClinicalTrials.gov — NCT06517810
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.