QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Recruiting

• Conditions: Acute Kidney Injury Due to Sepsis; Acute Kidney Injury
• Interventions: Device: QUELIMMUNE (SCD-PED)

• Registration Number: NCT06517810
• Lead Sponsor: SeaStar Medical

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study Start: 2024-07-19
• Study First Posted: 2024-07-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QUELIMMUNE Surveillance Registry Participants	QUELIMMUNE (SCD-PED)	All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.

Primary Outcome Measures

Name	Time	Method
Safety	28 days or through hospital discharge, whichever is sooner	New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner

Trial Locations

Locations (6)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States

UCSF Benioff Children's; 🇺🇸 San Francisco, California, United States

CS Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States