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NCT06517810Recruiting

QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

SeaStar Medical

Start Date

7/19/2024

Completion Date

8/1/2026

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

Eligibility Criteria

Age Range: No minimum to 22 years

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

Interventions

DEVICE

QUELIMMUNE (SCD-PED)

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Conditions

Acute Kidney InjuryAcute Kidney Injury Due to Sepsis

Locations

Children's of Alabama

Birmingham, Alabama 35233

United States

Lucile Packard Children's Hospital Stanford

Palo Alto, California 94304

United States

UCSF Benioff Children's

San Francisco, California 94618

United States

HealthONE HCA Rocky Mountain Children's Hospital

Denver, Colorado 80205

United States

Children's Hospital of Atlanta - Arthur M. Blank

Atlanta, Georgia 30329

United States

Children's Hospital of Atlanta - Scottish Rite

Atlanta, Georgia 30342

United States

Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

CS Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Cleveland Clinic Children's Hospital

Cleveland, Ohio 44106

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Monroe Carrell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Children's Medical Center Dallas

Dallas, Texas 75235

United States

Cook Children's Hospital

Fort Worth, Texas 76104

United States

Texas Children's Hospital

Houston, Texas 77030

United States