NCT06517810

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: SeaStar Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis

Interventions

Type	Name	Description
DEVICE	QUELIMMUNE (SCD-PED)	QUELIMMUNE device used as part of clinical practice.

Timeline

• Start date: 2024-07-19
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-24
• Last updated: 2026-03-23

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study