A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI

Stopped early · Not applicable

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT04869787

Run by

Children's Hospital Medical Center, Cincinnati

People needed

7

Starts

2021-05-17

Expected to finish

2023-10-27

Last updated by the study team

2024-01-10

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient's parent or legal representative has provided informed consent
• Must be receiving medical care in an intensive care unit
• Age less than 18 years.
• Body weight between ≥10 and ≤ 20 kilograms
• Intent to receive full supportive care through aggressive management
• Clinical diagnosis of AKI requiring CRRT
• At least one non-renal organ failure OR presence of proven/suspected sepsis

You may not qualify if…

• Threshold blood pressure of 80/40 mmHg
• 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
• Acute or chronic use of circulatory support device, other than extracorporeal membrane oxygenation (ECMO)
• 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
• AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity
• Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
• Chronic immunosuppression with the exception of corticosteroids up to a dose of 10 mg of prednisone per day
• Known positive HIV or AIDS or COVID-19
• Current Do not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days
• Patient not expected to survive 28 days because of an irreversible medical condition
• Any medical condition that the Investigator thinks may interfere with the study objectives
• Treating clinician does not feel it is in the best interest of the patient
• Platelet count <15,000/mm3
• Concurrent enrollment in another interventional clinical trial
• Use of any other investigational drug or device within the previous 30 days
• Use of AN-69 hemofilter membrane for CRRT

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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