QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Purpose
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
Conditions
- Acute Kidney Injury
- Acute Kidney Injury Due to Sepsis
Eligibility
- Eligible Ages
- Under 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| QUELIMMUNE Surveillance Registry Participants | All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry. |
|
Recruiting Locations
Monroe Carrell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- SeaStar Medical