QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

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

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Key information

Conditions

Acute Kidney Injury Acute Kidney Injury Due to Sepsis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QUELIMMUNE (SCD-PED)

Device

QUELIMMUNE device used as part of clinical practice.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin K Chung, MD

CONTACT

[email protected]

844-427-8100

Mohamed Zidan, MD

CONTACT

[email protected]

844-427-8100

Sponsors and collaborators

Lead sponsor

SeaStar Medical

Industry

Registry information

Official study title

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

Acronym: SAVE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 24, 2024
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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