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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 22
Healthy Volunteers: f
View:

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

Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
California
Lucile Packard Children's Hospital Stanford
RECRUITING
Palo Alto
UCSF Benioff Children's
RECRUITING
San Francisco
Illinois
Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Michigan
CS Mott Children's Hospital
NOT_YET_RECRUITING
Ann Arbor
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Texas
Cook Children's Hospital
RECRUITING
Fort Worth
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Mohamed Zidan, MD
mzidan@seastarmed.com
844-427-8100
Backup
Kevin K Chung, MD
kchung@seastarmed.com
844-427-8100
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2026-05
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: SeaStar Medical

This content was sourced from clinicaltrials.gov