Recruiting

Observational Study

Sponsor:

SeaStar Medical

Code:

NCT06517810

Conditions

Acute Kidney Injury

Acute Kidney Injury Due to Sepsis

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Interventions

QUELIMMUNE (SCD-PED)

Study Details

Brief summary:

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

Conditions

Acute Kidney Injury

Acute Kidney Injury Due to Sepsis

Study ID

NCT06517810

Start date

Jul 19, 2024

Status verified date

May, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

QUELIMMUNE (SCD-PED)

QUELIMMUNE device used as part of clinical practice.

Primary outcome measure

  • Safety [ Time Frame: 28 days or through hospital discharge, whichever is sooner ]

Central Contacts and Locations

Central contacts

Mohamed Zidan, MD

844-427-8100mzidan@seastarmed.com

Kevin K Chung, MD

844-427-8100kchung@seastarmed.com

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94304

UCSF Benioff Children's

Recruiting

San Francisco, California, United States, 94618

HealthONE HCA Rocky Mountain Children's Hospital

Recruiting

Denver, Colorado, United States, 80205

Children's Hospital of Atlanta - Arthur M. Blank

Recruiting

Atlanta, Georgia, United States, 30329

Children's Hospital of Atlanta - Scottish Rite

Recruiting

Atlanta, Georgia, United States, 30342

Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

CS Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Cleveland Clinic Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Monroe Carrell Jr Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Children's Medical Center Dallas

Recruiting

Dallas, Texas, United States, 75235

Cook Children's Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

SeaStar Medical

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • continuous kidney replacement therapy
  • continuous renal replacement therapy
  • acute kidney injury
  • organ failure
  • inflammation
  • dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SeaStar Medical on 2026-05-14.