QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Recruiting now

Conditions studied: Acute Kidney Injury, Acute Kidney Injury Due to Sepsis

In brief

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

Key facts

Study ID

NCT06517810

Run by

SeaStar Medical

People needed

50

Starts

2024-07-19

Expected to finish

2026-08-01

Last updated by the study team

2026-05-14

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (enrolling)
• UCSF Benioff Children's — San Francisco, California, United States (enrolling)
• HealthONE HCA Rocky Mountain Children's Hospital — Denver, Colorado, United States (enrolling)
• Children's Hospital of Atlanta - Arthur M. Blank — Atlanta, Georgia, United States (enrolling)
• Children's Hospital of Atlanta - Scottish Rite — Atlanta, Georgia, United States (enrolling)
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Monroe Carrell Jr Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (enrolling)
• Children's Medical Center Dallas — Dallas, Texas, United States (enrolling)
• Cook Children's Hospital — Fort Worth, Texas, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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