Registry for pediatric patients with acute kidney injury due to sepsis receiving QUELIMMUNE
Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
This study is looking to see if a treatment called QUELIMMUNE is safe for kids with kidney injury from sepsis and if it helps reduce new infections compared to those getting standard kidney treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 22 Years |
| Sex | All |
| Sponsor | SeaStar Medical Industry-sponsored |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Trial ID | NCT06517810 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect safety data on pediatric patients treated with QUELIMMUNE for acute kidney injury (AKI) due to sepsis. The study will compare the incidence of new bloodstream infections in patients receiving QUELIMMUNE to a matched group of patients receiving continuous kidney replacement therapy without QUELIMMUNE. The registry focuses on patients aged 10kg to 22 years who are on antibiotic therapy and require renal replacement therapy. Data will be collected prospectively to assess the safety and effectiveness of QUELIMMUNE in this population.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 10kg to 22 years with acute kidney injury due to sepsis requiring renal replacement therapy.
Not a fit: Patients weighing less than 10kg or older than 22 years, as well as those with known allergies to QUELIMMUNE components, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of QUELIMMUNE for treating pediatric AKI due to sepsis.
How similar studies have performed: While this approach is focused on a specific treatment, similar observational studies have shown success in collecting safety data for pediatric interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 14 other locations
- Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (Recruiting)
- UCSF Benioff Children's — San Francisco, California, United States (Recruiting)
- HealthONE HCA Rocky Mountain Children's Hospital — Denver, Colorado, United States (Not_yet_recruiting)
- Children's Hospital of Atlanta - Arthur M. Blank — Atlanta, Georgia, United States (Not_yet_recruiting)
- Children's Hospital of Atlanta - Scottish Rite — Atlanta, Georgia, United States (Recruiting)
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- CS Mott Children's Hospital — Ann Arbor, Michigan, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Monroe Carrell Jr Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
- Children's Medical Center Dallas — Dallas, Texas, United States (Recruiting)
- Cook Children's Hospital — Fort Worth, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Mohamed Zidan, MD
- Email: mzidan@seastarmed.com
- Phone: 844-427-8100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.