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

Acute Kidney Injury Clinical Trial

— SCD-PED-01  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820350
• Other study ID #: SCD-PED-01
• Secondary ID: FD005092-01
• Status: Completed
• Phase: N/A
• Start date: December 4, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2024
• Source: CytoPherx, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 22 Years

Eligibility

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. Irreversible brain damage based on available historical and clinical information.

2. Presence of any organ transplant at any time.

3. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).

4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.

5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome(b), thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine, or tacrolimus nephrotoxicity

6. Received >12hrs of CRRT during this hospital admission or prior to transfer from an outside hospital.

7. Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.

8. Hospitalization >14 days during this hospital admission and 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.

11. HIV or AIDS.

12. Severe liver failure(c).

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 is moribund or chronically debilitated for whom full supportive care is not indicated.

15. 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.)

16. Any medical condition that the Investigator thinks may interfere with the study objectives.

17. Physician refusal.

18. Dry weight of <20kg(d).

19. Platelet count <30,000/mm3 at time of screening(e).

20. 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.

21. Use of any other Investigational drug or device within the previous 30 days.

1. ECMO was subsequently removed as an exclusion. Two patients in the study received ECMO.

2. Hemolytic uremic syndrome subsequently removed as an exclusion. One patient in the study had HUS.

3. Severe liver failure was change to severe chronic liver failure during the study course.

4. The lower weight limit threshold was decreased to 15 kg after consultation and approval from the US FDA.

5. The thrombocytopenia exclusion removed after no observed occurrences in the first five subjects.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Device:
• SCD-F40
CRRT with SCD

Locations

Country	Name	City	State
United States	CS Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
CytoPherx, Inc	Children's Hospital Medical Center, Cincinnati, Innovative BioTherapies (IBT)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Goldstein SL, Askenazi DJ, Basu RK, Selewski DT, Paden ML, Krallman KA, Kirby CL, Mottes TA, Terrell T, Humes HD. Use of the Selective Cytopheretic Device in Critically Ill Children. Kidney Int Rep. 2020 Dec 19;6(3):775-784. doi: 10.1016/j.ekir.2020.12.010. eCollection 2021 Mar. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse events related to device treatment occurring during and 60 days post treatment initiation	60 days post treatment initiation
Secondary	All Cause Mortality Through 60 Days Post-randomization.	The effect of SCD treatment on all cause mortality through 60 days post-randomization.	Day 60
Secondary	Mortality at Day 28	Mortality at day 28 following treatment	Day 28 following treatment
Secondary	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.	60 days

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