Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury

Stopped early · Not applicable

Conditions studied: Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT01400893

Run by

SeaStar Medical

People needed

134

Starts

2011-08-01

Expected to finish

2013-09-01

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• Dry weight of >150 kg.
• More than one hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
• Platelet count <30,000/mm3 at time of screening.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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