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

May 11, 2026 updated by: SeaStar Medical

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 28 days or through hospital discharge, whichever is sooner
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

This is where you will find people and organizations involved with this study.

Sponsor

SeaStar Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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