QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QUELIMMUNE (SCD-PED).
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Acute Kidney Injury Due to Sepsis. Basic parameters: up to 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
Overview
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
Interventions
- Device QUELIMMUNE (SCD-PED)
QUELIMMUNE device used as part of clinical practice.
Primary outcome measures
- Safety [Time frame: 28 days or through hospital discharge, whichever is sooner]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 15 centers
- Children's of Alabama — Birmingham
- Lucile Packard Children's Hospital Stanford — Palo Alto
- UCSF Benioff Children's — San Francisco
- HealthONE HCA Rocky Mountain Children's Hospital — Denver
- Children's Hospital of Atlanta - Arthur M. Blank — Atlanta
- Children's Hospital of Atlanta - Scottish Rite — Atlanta
- Lurie Children's Hospital of Chicago — Chicago
- CS Mott Children's Hospital — Ann Arbor
- … and 7 more centers
Identifiers
NCT: NCT06517810 · SCD-PED-HDE-1