Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kid… (NCT02820350) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
United States19 participantsStarted 2016-12-04
Plain-language summary
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)
Who can participate
Age range2 Years – 22 Years
SexALL
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Inclusion criteria
✓. A patient, or legal representative, has signed a written informed consent form.
✓. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma).
✓. Age less than 22 years.
✓. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
✓. Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
✓. Clinical diagnosis of AKI due to etiologies requiring CRRT (see Appendix B). AKI is defined as acute kidney injury with any one of the following:
✓. At least one non-renal organ failure (defined as receiving mechanical ventilation or at least one vasoactive medication to treat hypotension) OR presence (proven or suspected) of sepsis. (Appendix C).
Exclusion criteria
✕. Irreversible brain damage based on available historical and clinical information.
✕. Presence of any organ transplant at any time.
✕. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
✕. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.