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QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

NCT06517810 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DEVICE

QUELIMMUNE (SCD-PED)

QUELIMMUNE device used as part of clinical practice.

Sponsors & Collaborators

  • SeaStar Medical

    lead INDUSTRY

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2026-05-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517810 on ClinicalTrials.gov