Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
NCT ID: NCT01400893
Last Updated: 2021-04-27
Study Results
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View full resultsBasic Information
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TERMINATED
NA
134 participants
INTERVENTIONAL
2011-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CRRT + SCD
Patients with a diagnosis of AKI requires CRRT will be randomized
SCD
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. 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 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.
CRRT alone
Patients with a diagnosis of AKI requires CRRT will be randomized
No interventions assigned to this group
Interventions
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SCD
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. 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 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.
Eligibility Criteria
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Inclusion Criteria
2. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma).
3. Age 18 to 80 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. Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.
6. Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
7. A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as Acute Kidney Injury occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average \<20 mL/hr) for \>6-12 hours or: an increase in serum creatinine ≥2 mg/dL (≥1.5 mg/dL in females) over a period of ≤4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)
8. Presence of at least one non-renal organ failure or present sepsis as defined in Appendix C.
9. All patients must be able to tolerate regional citrate anticoagulation.
Exclusion Criteria
2. Presence of any organ transplant at any time.
3. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO.
4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.
5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine or tacrolimus nephrotoxicity.
6. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy.
7. Chronic immunosuppression (e.g., HIV/AIDS, chronic glucocorticoid therapy \>20 mg/day prednisone equivalent on a chronic basis). The acute use of glucocorticoids is permissible.
8. Severe liver failure as documented by a Child-Pugh Liver Failure Score \>12 (see Appendix F).
9. Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the next 7 days.
10. Currently in Comfort measures Only or Comfort Measures Only status anticipated within next 7 days.
11. Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
12. 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.)
13. Any medical condition that the Investigator thinks may interfere with the study objectives.
14. Physician refusal.
15. Patient is a prisoner.
16. Dry weight of \>150 kg.
17. More than one hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
18. Platelet count \<30,000/mm3 at time of screening.
19. 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.
20. Use of any other Investigational drug or device within the previous 30 days.
18 Years
80 Years
ALL
No
Sponsors
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SeaStar Medical
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of Florida
Gainesville, Florida, United States
University of Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Sanford Health
Fargo, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Memorial Hospital
Chattanooga, Tennessee, United States
Erlanger Hospital
Chattanooga, Tennessee, United States
Dallas VA Medical Center
Dallas, Texas, United States
University of Texas
Houston, Texas, United States
INOVA Health Care Services
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Tumlin JA, Galphin CM, Tolwani AJ, Chan MR, Vijayan A, Finkel K, Szamosfalvi B, Dev D, DaSilva JR, Astor BC, Yevzlin AS, Humes HD; SCD Investigator Group. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury. PLoS One. 2015 Aug 5;10(8):e0132482. doi: 10.1371/journal.pone.0132482. eCollection 2015.
Related Links
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Related Info
Other Identifiers
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SCD-003
Identifier Type: -
Identifier Source: org_study_id
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