← Back to Search

QUELIMMUNE Surveillance Registry Participants for Acute Kidney Failure (SAVE Trial)

N/A
Recruiting
Research Sponsored by SeaStar Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days or through hospital discharge, whichever is sooner
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Acute Kidney Failure
  • Acute Kidney Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days or through hospital discharge, whichever is sooner
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days or through hospital discharge, whichever is sooner for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: QUELIMMUNE Surveillance Registry ParticipantsExperimental Treatment1 Intervention
All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.

Find a Location

Who is running the clinical trial?

SeaStar MedicalLead Sponsor
5 Previous Clinical Trials
391 Total Patients Enrolled
~200 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top