Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
Conditions
Keywords
continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis
Brief 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
Interventions
DEVICEQUELIMMUNE (SCD-PED)
QUELIMMUNE device used as part of clinical practice.
Sponsors
SeaStar Medical
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 22 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 28 days or through hospital discharge, whichever is sooner | New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner |
Countries
United States
Contacts
CONTACTMohamed Zidan, MD
CONTACTKevin K Chung, MD
Outcome results
None listed