Registry for pediatric patients with acute kidney injury due to sepsis receiving QUELIMMUNE
Official title: Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
Run by SeaStar Medical · NCT06517810 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 22 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | SeaStar Medical Industry-sponsored |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Status | Recruiting |
| Started | July 19, 2024 |
| Main results expected | May 2026 |
| Study ends | August 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT06517810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients aged 10kg to 22 years with acute kidney injury due to sepsis requiring renal replacement therapy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is focused on a specific treatment, similar observational studies have shown success in collecting safety data for pediatric interventions.
Who can join: the full rules
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 it's running
-
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 Recruiting -
Children's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, United States Recruiting -
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, United States Recruiting
Show 9 more locations
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Remote Ischemic Preconditioning at Different Times After Heart Valve Surgery
This study tests whether applying brief, controlled blood-flow restrictions to a limb at different times after heart valve surgery can help protect organs and reduce complications like kidney injury.
-
Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes
This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.
-
Biomarkers to predict CSA-AKI risk before heart surgery
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Perioperative GFR Monitoring to Predict CSA-AKI and CA-AKI
This study tests whether perioperative transcutaneous fluorescence GFR measurements can predict CSA-AKI or CA-AKI in adults undergoing cardiovascular procedures or iodine contrast exposure.
-
Gut microbes and blood signals in sepsis-related liver and kidney injury
This study tests whether gut microbes and blood markers differ in adults with sepsis who develop liver or kidney injury, compared with healthy volunteers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.