QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Recruiting
Observational Study
Acute Kidney Injury
Acute Kidney Injury Due to Sepsis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- Up to 22
- Sex
- Any
- Study type
- Observational
- Participants needed
- 50 (estimated)
- Sponsor
- SeaStar Medical · Industry
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About This Trial
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 n…
Trial Locations
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Eligibility Criteria
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
Contacts