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

NCT02820350 | Completed Results DMC

• 2 other identifiers: SCD-PED-01FD005092-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

Acute Kidney Injury

Keywords

Acute Renal Failure; Acute kidney injury; Continuous Renal Replacement Therapy; Selective cytopheretic device; Pediatric

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse events related to device treatment occurring during and 60 days post treatment initiation

  60 days post treatment initiation

Secondary Outcomes (3)

• All Cause Mortality Through 60 Days Post-randomization.

  Day 60

• Mortality at Day 28

  Day 28 following treatment

• The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.

  60 days

Study Arms (1)

Treatment

OTHER

Treatment arm only

Device: SCD-F40

Interventions

SCD-F40 DEVICE

CRRT with SCD

Also known as: Selective Cytopheretic Device (SCD)

Treatment

Eligibility Criteria

• Age: 2 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Irreversible brain damage based on available historical and clinical information.
• Presence of any organ transplant at any time.
• Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
• Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.
• 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
• Received \>12hrs of CRRT 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.
• Hospitalization \>14 days during this hospital admission and 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.
• HIV or AIDS.
• Severe liver failure(c).
• 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 is moribund or chronically debilitated for whom full supportive care is not indicated.
• 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.)

Sponsors & Collaborators

• CytoPherx, Inc: lead
• Innovative BioTherapies (IBT): collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (4)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

CS Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related 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.

  PMID: 33732992 BACKGROUND

Related Links

• Digital Object Identifier)

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Eric Schlorff, CEO
• Organization: SeaStar Medical

eric@seastarmed.com

844-427-8100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 30, 2016
• Study Start: December 4, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)