QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Description

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

Study Overview

Study Details

Study overview

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

Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children with Acute Kidney Injury: a Humanitarian Device Exemption (HDE) Surveillance Registry Protocol

QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Chicago

Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
  • * Weight ≤10kg
  • * Age \>22 years
  • * Known allergy to any components of QUELIMMUNE

Ages Eligible for Study

to 22 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SeaStar Medical,

Study Record Dates

2026-05