A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI (NCT04869787) | Clinical Trial Compass
TerminatedNot Applicable
A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI
Stopped: The device manufacturer has received a HDE for this population from the FDA
United States7 participantsStarted 2021-05-17
Plain-language summary
The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI). AKI promotes a systemic inflammatory response syndrome (SIRS) which results in systemic microvascular damage and, if severe, multi-organ dysfunction. Activated circulating leukocytes play a central role in this process. The SCD is a synthetic membrane with the ability to bind activated leukocytes and, when used in a continuous renal replacement therapy (CRRT) extracorporeal circuit in the presence of regional citrate anticoagulation, modulates inflammation. The SCD PED-02 study will test the primary hypothesis that up to ten sequential 24-hour SCD treatments in pediatric patients with AKI will be completed safely and improve survival compared to historical controls who received CRRT alone.
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
ā. The patient's parent or legal representative has provided informed consent
ā. Must be receiving medical care in an intensive care unit
ā. Age less than 18 years.
ā. Body weight between ā„10 and ā¤ 20 kilograms
ā. Intent to receive full supportive care through aggressive management
ā. Clinical diagnosis of AKI requiring CRRT
ā. At least one non-renal organ failure OR presence of proven/suspected sepsis
Exclusion criteria
ā. Threshold blood pressure of 80/40 mmHg
ā. Patients with a solid organ transplant or those with a bone marrow or stem cell transplant in the previous 100 days or who have not engrafted
ā. Acute or chronic use of circulatory support device, other than extracorporeal membrane oxygenation (ECMO)
What they're measuring
1
Number of SCD-related Adverse Events (AE)
Timeframe: From enrollment to Day 60 post treatment
2
Number of Unanticipated Adverse Device Effects (UADE)
Timeframe: From enrollment to Day 60 post treatment
Trial details
NCT IDNCT04869787
SponsorChildren's Hospital Medical Center, Cincinnati
ā. Presence of preexisting advanced chronic renal failure on chronic renal replacement therapy or with an estimated glomerular filtration rate less than 30 mL/min/1.73m2
ā. AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity
ā. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
ā. Chronic immunosuppression with the exception of corticosteroids up to a dose of 10 mg of prednisone per day