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

Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Age Range:2 - 22
Start Date:October 2016
End Date:March 31, 2020
Contact:H. David Humes, MD

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A Multi-Center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI)

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)

The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter
cartridge. The device is connected in series to commercially available Continuous Renal
Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT
hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through
this space and it is returned to the patient via the venous return line of the CRRT circuit.
Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

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,

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

6. AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis,
atheroembolism, functional or surgical nephrectomy, cyclosporine, or tacrolimus

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

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

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. -
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