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

March 17, 2022 updated by: SeaStar Medical

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)

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Nephrology
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  11. Do Not Resuscitate (DNR) status.
  12. Comfort measures only.
  13. Patient is moribund or for whom full supportive care is not indicated.
  14. Patient not expected to survive 28 days because of an irreversible medical condition.
  15. Any medical condition that the Investigator thinks may interfere with the study objectives.
  16. Physician refusal.
  17. Patient pregnant.
  18. Patient is a prisoner.
  19. Pre-morbid weight >128.5 kg.
  20. More than one hemodialysis treatment or longer than 24 hours since starting CRRT.
  21. Platelet count <30,000/mm3.
  22. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and or samples are taken (NO TEST DEVICE OR DRUG USED) are allowed to participate.
  23. Use of any other Investigational drug or device within the previous 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCD
Selective Cytopheretic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60 Day Mortality
Time Frame: Day 60 following treatment end
Day 60 following treatment end
60 Day Renal Recovery
Time Frame: Day 60 following treatment end
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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