QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry (SAVE)

SeaStar Medical

Status: Enrolling

Conditions: Acute Kidney Injury Due to Sepsis; Acute Kidney Injury

Treatments: Device: QUELIMMUNE (SCD-PED)

Study type: Observational

Funder types: Industry

Identifiers

NCT06517810

SCD-PED-HDE-1

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

QUELIMMUNE Surveillance Registry Participants

Description:

All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.

Treatment:

Device: QUELIMMUNE (SCD-PED)