Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)
1 other identifier
interventional
134
1 country
26
Brief Summary
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Typical duration for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
August 29, 2017
CompletedApril 27, 2021
April 1, 2021
2.1 years
July 21, 2011
March 14, 2017
April 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
All cause mortality through day 60 post-randomization. The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.
Day 60 following treatment initiation
Secondary Outcomes (1)
Renal Replacement Therapy Dependency at Day 60.
Day 60 following treatment initiation
Study Arms (2)
CRRT + SCD
EXPERIMENTALPatients with a diagnosis of AKI requires CRRT will be randomized
CRRT alone
NO INTERVENTIONPatients with a diagnosis of AKI requires CRRT will be randomized
Interventions
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
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 18 to 80 years.
- Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
- Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.
- Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
- 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.)
- Presence of at least one non-renal organ failure or present sepsis as defined in Appendix C.
- All patients must be able to tolerate regional citrate anticoagulation.
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.
- Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.
- 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.
- 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 (e.g., HIV/AIDS, chronic glucocorticoid therapy \>20 mg/day prednisone equivalent on a chronic basis). The acute use of glucocorticoids is permissible.
- Severe liver failure as documented by a Child-Pugh Liver Failure Score \>12 (see Appendix F).
- Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the next 7 days.
- Currently in Comfort measures Only or Comfort Measures Only status anticipated within 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.)
- Any medical condition that the Investigator thinks may interfere with the study objectives.
- Physician refusal.
- Patient is a prisoner.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SeaStar Medicallead
Study Sites (26)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
UCLA
Los Angeles, California, 90025, United States
University of California, San Diego
San Diego, California, 92103, United States
University of Florida
Gainesville, Florida, 32611, United States
University of Florida
Jacksonville, Florida, 32209, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Washington University
St Louis, Missouri, 63110, United States
Albany Medical College
Albany, New York, 12208, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Sanford Health
Fargo, North Dakota, 58122, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Memorial Hospital
Chattanooga, Tennessee, 37403, United States
Erlanger Hospital
Chattanooga, Tennessee, 37404, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
University of Texas
Houston, Texas, 77030, United States
INOVA Health Care Services
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 26244978RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- H. David Humes
- Organization
- CytoPherx, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 25, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
April 27, 2021
Results First Posted
August 29, 2017
Record last verified: 2021-04