Clinical trial NCT01400893: Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Renal Failure
Acute kidney injury
Acute tubular necrosis
Continuous Renal Replacement Therapy
Severe sepsis
Selective cytopheretic device
Lead sponsor: SeaStar Medical
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. A patient, or legal representative, has signed a written informed consent form.
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:

1. Irreversible brain damage based on available historical and clinical information.
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.

Primary outcomes:
measure: The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
timeFrame: Day 60 following treatment initiation
Secondary outcomes:
measure: Renal Replacement Therapy Dependency at Day 60.
timeFrame: Day 60 following treatment initiation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Falls Church
country: United States
facility: INOVA Health Care Services
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.