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Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure | Clinical Trials | Clareo Health

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

A Multi-Center Pilot Study to Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) Treatments In Patients With Acute Renal Failure (ARF)

NCT01072682•SeaStar Medical

View on ClinicalTrials.gov

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).

Detailed Description

Acute renal failure 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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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, Mixed, other).
•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 hours.
•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 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.)
•8. 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.
•9. All patients must be able to tolerate regional citrate anticoagulation.

Exclusion Criteria

•1. Contraindications to regional citrate anticoagulation.
•2. Irreversible brain damage based on available historical and clinical information.
•3. Presence of a renal transplant at any time.
•4. Non-candidacy for acute renal replacement therapy.
•5. Non-renal organ transplantation within six months of screening date.
•6. 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).
•7. 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.
•8. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
•9. 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
•10. Severe liver failure as documented by a Child-Pugh Liver Failure Score \>12.
+13 more criteria

Locations (7)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of California San Diego

San Diego, California, United States

Denver Nephrology

Denver, Colorado, United States

George Washington University

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

Mayo Clinic

Rochester, Minnesota, United States

Memorial Hospital

Chattanooga, Tennessee, United States

University of Texas

Houston, Texas, United States

Key Dates

Start Date

February 1, 2010

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

March 31, 2022

Enrollment

ACTUAL participants

Conditions

Acute Renal Failure

Interventions

Selective cytopheretic device (SCD)

DEVICE

Kidney Precision Medicine Project

NCT04334707

Acute Kidney FailureAcute Kidney Insufficiency+12 more

View study

TERMINATEDPHASE3

I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus deLayed in Intensive Care Unit)

NCT01682590

Septic ShockAcute Renal Failure (as Defined by the "Failure" Stage of the RIFLE Classification)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Kidney Precision Medicine Project

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