A Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). (SCD-PED-01)

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Renal Failure, Acute kidney injury, Continuous Renal Replacement Therapy, Selective cytopheretic device, Pediatric Read More

Inclusion Criteria:

1. A patient, or legal representative, has signed a written informed consent form.
2. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma).
3. Age less than 22 years.
4. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
5. Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.

6. 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:

   • Increase in SCr by ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours or;
   • Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days or;
   • Urine volume <0.5ml/kg/h for 6 hours
7. 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:

1. Threshold blood pressure of 80/40 mmHg-- patients with both a systolic blood pressure of less than 80 mmHg and a diastolic blood pressure of less than 40 mmHg.
2. Irreversible brain damage based on available historical and clinical information.
3. 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.
4. Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
5. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury or with pre-existing chronic kidney disease (CKD) defined as a eGFR<30ml/min/1.73m2. Patients who have never seen a pediatric nephrologist will be assumed not to have pre-existing CKD.
6. AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine, or tacrolimus nephrotoxicity.
7. Received >12 hour of CRRT (not including SCUF on ECMO) during this hospital admission or prior to transfer from an outside hospital.
8. Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
9. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy.
10. Chronic immunosuppression with the exception of corticosteroids up to a dose of 10mg per day.
11. HIV or AIDS.
12. Severe chronic liver failure as determined by standard diagnostic requirements.
13. 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.
14. Patient not expected to survive 28 days because of an irreversible medical condition. (This is not restrictive to AKI, and may include situations such as the presence of irreversible brain damage, untreatable malignancy, inoperable life threatening condition, or any condition to which therapy is regarded as futile by the PI.)
15. Any medical condition that the Investigator thinks may interfere with the study objectives.
16. Physician refusal.
17. Dry weight of <15 kg.
18. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and/or samples are taken (NO TEST DEVICE OR TEST DRUG USED) are allowed to participate.
19. Use of any other Investigational drug or device within the previous 30 days. -