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 range
2 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.