The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to commercially available Continuous Renal Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
CRRT with SCD
Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Adverse Events
Adverse events related to device treatment occurring during and 60 days post treatment initiation
Time frame: 60 days post treatment initiation
All Cause Mortality Through 60 Days Post-randomization.
The effect of SCD treatment on all cause mortality through 60 days post-randomization.
Time frame: Day 60
Mortality at Day 28
Mortality at day 28 following treatment
Time frame: Day 28 following treatment
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.
RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.
Time frame: 60 days
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