Summary

Eligibility
for people ages up to 22 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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

Official Title

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

Keywords

Acute Kidney Injury, Acute Kidney Injury Due to Sepsis, continuous kidney replacement therapy, continuous renal replacement therapy, organ failure, inflammation, dialysis, Wounds and Injuries, QUELIMMUNE (SCD-PED)

Eligibility

You can join if…

Open to people ages up to 22 years

  • All patients initiated on QUELIMMUNE therapy under the HDE-approved indication

You CAN'T join if...

  • Weight ≤10kg
  • Age >22 years
  • Known allergy to any components of QUELIMMUNE

Locations

  • UCSF Benioff Children's accepting new patients
    San Francisco California 94618 United States
  • Lucile Packard Children's Hospital Stanford not yet accepting patients
    Palo Alto California 94304 United States
  • Children's of Alabama accepting new patients
    Birmingham Alabama 35233 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SeaStar Medical
ID
NCT06517810
Study Type
Observational [Patient Registry]
Participants
Expecting 300 study participants
Last Updated