NCT06517810 QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
| NCT ID | NCT06517810 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SeaStar Medical |
| Condition | Acute Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-07-19 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06517810 clinical trial?
This trial is open to participants of all sexes, up to 22 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06517810 currently recruiting?
Yes, NCT06517810 is actively recruiting participants. Contact the research team at mzidan@seastarmed.com for enrollment information.
Where is the NCT06517810 trial being conducted?
This trial is being conducted at Birmingham, United States, Palo Alto, United States, San Francisco, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT06517810 clinical trial?
NCT06517810 is sponsored by SeaStar Medical. The trial plans to enroll 50 participants.
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