QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry (SAVE)

Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol

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

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Acute Kidney Injury Due to Sepsis
• Intervention / Treatment: Device: QUELIMMUNE (SCD-PED)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mohamed Zidan, MD; Phone Number: 844-427-8100; Email: mzidan@seastarmed.com
• Study Contact Backup: Name: Kevin K Chung, MD; Phone Number: 844-427-8100; Email: kchung@seastarmed.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Children's of Alabama
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucile Packard Children's Hospital Stanford
    • San Francisco, California, United States, 94618
      • Recruiting
      • UCSF Benioff Children's
  • Colorado
    • Denver, Colorado, United States, 80205
      • Recruiting
      • HealthONE HCA Rocky Mountain Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Hospital of Atlanta - Scottish Rite
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Hospital of Atlanta - Arthur M. Blank
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lurie Children's Hospital of Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • CS Mott Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Cleveland Clinic Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Monroe Carrell Jr Children's Hospital at Vanderbilt
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Children's Medical Center Dallas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Cook Children's Hospital
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QUELIMMUNE Surveillance Registry Participants; All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.	Device: QUELIMMUNE (SCD-PED); QUELIMMUNE device used as part of clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner	28 days or through hospital discharge, whichever is sooner

Collaborators and Investigators

• Sponsor: SeaStar Medical

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dialysis; acute kidney injury; inflammation; continuous renal replacement therapy; organ failure; continuous kidney replacement therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Inflammation
• Other Study ID Numbers: SCD-PED-HDE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No