Acute Kidney InjurySAVENCT06517810
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
An observational study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, run by SeaStar Medical at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
- What is being tested?
- QUELIMMUNE (SCD-PED)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- 19 Jul 2024to Aug 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
Who cannot join
- Weight <10kg
- Age >22 years
- Known allergy to any components of QUELIMMUNE
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
- Recruiting
Children's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, 30329
- Recruiting
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
- Recruiting
Children's of Alabama
Birmingham, Alabama, 35233
- Recruiting
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Recruiting
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44106
- Recruiting
Children's Medical Center Dallas
Dallas, Texas, 75235
- Recruiting
HealthONE HCA Rocky Mountain Children's Hospital
Denver, Colorado, 80205
- Recruiting
Cook Children's Hospital
Fort Worth, Texas, 76104
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
- Recruiting
Monroe Carrell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
- Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
UCSF Benioff Children's
San Francisco, California, 94618
About this study
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
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
- Being tested
- QUELIMMUNE (SCD-PED)
- Keywords
- continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis
- Medical subject headings
- Acute Kidney Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUELIMMUNE (SCD-PED)Device
QUELIMMUNE device used as part of clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: QUELIMMUNE (SCD-PED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner
Measured: 28 days or through hospital discharge, whichever is sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start19 Jul 2024
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517810
- Sponsor's protocol ID
- SCD-PED-HDE-1
- Acronym
- SAVE
- Status last verified
- May 2026
- First submitted
- 18 Jul 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06517810
- Acronym / sponsor ID
- SAVE / SCD-PED-HDE-1
- Keywords
- continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QUELIMMUNE Surveillance Registry Participants | – | Device: QUELIMMUNE (SCD-PED)All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
Key exclusion criteria (3 listed)
- Weight <10kg
- Age >22 years
- Known allergy to any components of QUELIMMUNE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUELIMMUNE (SCD-PED)QUELIMMUNE device used as part of clinical practice. | Device | QUELIMMUNE Surveillance Registry Participants |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, run by SeaStar Medical at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zidan, MD (844-427-8100, mzidan@seastarmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days or through hospital discharge, whichever is sooner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.