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
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is described as a surveillance registry rather than a treatment trial, does that mean my child would just be observed and have data collected, rather than receiving any experimental drug or intervention?
2The registry is specifically focused on acute kidney injury related to sepsis in children — does my child's particular diagnosis and situation match what this registry is designed to study?
3What safety information is being collected, and is there any risk to my child from participating — for example, would it require extra blood draws, procedures, or hospital visits beyond what their normal care already involves?
4Since this is a registry study with no listed phase, how might the data collected here eventually be used to help children with sepsis-related kidney injury in the future, and does participating have any direct benefit for my child right now?
5Are there other treatment trials or standard-of-care options for my child's acute kidney injury that I should consider alongside or instead of enrolling in this registry?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety
Timeframe: 28 days or through hospital discharge, whichever is sooner