Status:
TERMINATED
A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
University of Michigan
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief 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 synd...
Detailed Description
The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI). Importantly, acute kidney injury is a highly letha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04869787
Start Date
May 17 2021
End Date
October 27 2023
Last Update
January 10 2024
Active Locations (2)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229