QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
SeaStar Medical
Study ID
NCT06517810
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Acute Kidney Injury Due to Sepsis

Eligibility Criteria

Sex
ALL
Age
N/A - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • QUELIMMUNE (SCD-PED) — DEVICE
    QUELIMMUNE device used as part of clinical practice.

Study Details

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 Dates

Start date
Jul 19, 2024
Status verified
May 2026
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: QUELIMMUNE Surveillance Registry Participants
    All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.

Primary Outcome Measure

Safety [ Time Frame: 28 days or through hospital discharge, whichever is sooner ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233-
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304-
UCSF Benioff Children'sSan FranciscoCalifornia94618-
HealthONE HCA Rocky Mountain Children's HospitalDenverColorado80205-
Children's Hospital of Atlanta - Arthur M. BlankAtlantaGeorgia30329-
Children's Hospital of Atlanta - Scottish RiteAtlantaGeorgia30342-
Lurie Children's Hospital of ChicagoChicagoIllinois60611-
CS Mott Children's HospitalAnn ArborMichigan48109-
Cincinnati Children's HospitalCincinnatiOhio45229-
Cleveland Clinic Children's HospitalClevelandOhio44106-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Monroe Carrell Jr Children's Hospital at VanderbiltNashvilleTennessee37232-
Children's Medical Center DallasDallasTexas75235-
Cook Children's HospitalFort WorthTexas76104-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
Children's of Alabama· Birmingham, ALLucile Packard Children's Hospital Stanford· Palo Alto, CAUCSF Benioff Children's· San Francisco, CAHealthONE HCA Rocky Mountain Children's Hospital· Denver, COChildren's Hospital of Atlanta - Arthur M. Blank· Atlanta, GAChildren's Hospital of Atlanta - Scottish Rite· Atlanta, GA

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