Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure

NCT01072682 | Completed Results

• 1 other identifier: ARF002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 7

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 renal failure (ARF).

Conditions

Acute Renal Failure

Keywords

Acute Renal Failure; Acute tubular necrosis; Continuous Renal Replacement Therapy; Selective cytopheretic device

Outcome Measures

Primary Outcomes (2)

• 60 Day Mortality

  Day 60 following treatment end

• 60 Day Renal Recovery

  The criteria used to measure Renal Recovery requires the patient to be dependent free of CRRT and/or chronic dialysis.

  Day 60 following treatment end

Study Arms (1)

SCD

EXPERIMENTAL

Selective Cytopheretic Device

Device: Selective cytopheretic device (SCD)

Interventions

Selective cytopheretic device (SCD) DEVICE

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.

SCD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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, Mixed, other).
• 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 hours.
• 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 renal failure 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.)
• At least one non-renal organ failure (modified SOFA organ system score \>2), as defined in Appendix A or presence (proven or suspected) of sepsis as defined in Appendix B.
• All patients must be able to tolerate regional citrate anticoagulation.

You may not qualify if:

• Contraindications to regional citrate anticoagulation.
• Irreversible brain damage based on available historical and clinical information.
• Presence of a renal transplant at any time.
• Non-candidacy for acute renal replacement therapy.
• Non-renal organ transplantation within six months of screening date.
• Presence of preexisting chronic renal failure prior to this episode of ARF. Preexisting chronic renal failure is defined as baseline serum creatinine \>2.5 mg/dL (men), or \>2.0 mg/dL (women).
• ARF 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., AIDS, chronic glucocorticoid therapy \>20 mg/day prednisone equivalent on a chronic basis, or chemotherapy). The acute use of glucocorticoids is permissible
• Severe liver failure as documented by a Child-Pugh Liver Failure Score \>12.
• Do Not Resuscitate (DNR) status.
• Comfort measures only.
• Patient is moribund or for whom full supportive care is not indicated.
• Patient not expected to survive 28 days because of an irreversible medical condition.
• Any medical condition that the Investigator thinks may interfere with the study objectives.

Sponsors & Collaborators

• SeaStar Medical: lead
• Baim Institute for Clinical Research: collaborator
• Medtox: collaborator

Study Sites (7)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Denver Nephrology

Denver, Colorado, 80230, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Cortex Necrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Eric Schlorff
• Organization: SeaStar Medical, Inc

eric@seastarmed.com

8444278100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 31, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-03

Locations

US (7)