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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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)

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Device: SCD-F40


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient, or legal representative, has signed a written informed consent form. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma). Age less than 22 years. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum. Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours. 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 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: 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. Irreversible brain damage based on available historical and clinical information. 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 ECMO such as LVADs, RVADs, BIVADs. 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. AKI occurring in the setting of burns, obstructive uropathy, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine, or tacrolimus nephrotoxicity. Received >12 hour of CRRT (not including SCUF on ECMO) during this hospital admission or prior to transfer from an outside hospital. Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital. 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 10mg per day. HIV or AIDS. Severe chronic liver failure as determined by standard diagnostic requirements. 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. (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.) Any medical condition that the Investigator thinks may interfere with the study objectives. Physician refusal. Dry weight of <15 kg. 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. Use of any other Investigational drug or device within the previous 30 days. -

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SCD-F40|CRRT with SCD|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective: Adverse events related to treatment occurring during and 60 days post treatment initiation. | The primary clinical endpoint in this trial is safety of SCD treatment after up to seven consecutive 24 hour therapy sessions. Safety as determined with adverse events related to treatment up to 60 days following treatment initiation. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of SCD treatment on all cause mortality through 60 days post-randomization. | The effect of SCD treatment on all cause mortality through 60 days post-randomization. | Day 60 following treatment end | 
| The effect of SCD treatment on Renal Replacement Therapy dependency at day 60. | RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy. | Day 60 following treatment end | 
| Mortality at day 28 | Mortality at day 28 following treatment | Day 28 following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Renal Failure, Acute kidney injury, Continuous Renal Replacement Therapy, Selective cytopheretic device, Pediatric