Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
- Conditions
- Acute Kidney Injury
- Interventions
- Device: SCD
- Registration Number
- NCT01400893
- Lead Sponsor
- SeaStar Medical
- 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).
- Detailed Description
Acute kidney injury is a condition where the kidneys are not capable of producing adequate urine. Therefore, another way to remove waste from the body is needed to hopefully allow time for the kidneys to heal. One method of removing waste from the body is called Continuous Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will be followed up until day 60 following the treatment.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 134
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRRT + SCD SCD Patients with a diagnosis of AKI requires CRRT will be randomized
- Primary Outcome Measures
Name Time Method The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization. Day 60 following treatment initiation 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.
- Secondary Outcome Measures
Name Time Method Renal Replacement Therapy Dependency at Day 60. Day 60 following treatment initiation 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.
Trial Locations
- Locations (25)
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Erlanger Hospital
🇺🇸Chattanooga, Tennessee, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Albany Medical College
🇺🇸Albany, New York, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
INOVA Health Care Services
🇺🇸Falls Church, Virginia, United States
Northwestern University
🇺🇸Chicago, Illinois, 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
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
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 Iowa
🇺🇸Iowa City, Iowa, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Sanford Health
🇺🇸Fargo, North Dakota, United States
Memorial Hospital
🇺🇸Chattanooga, Tennessee, United States
University of Texas
🇺🇸Houston, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States