Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients

Description

Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.

Study Start Date

January 2012

Estimated Completion Date

June 2018

Interventions

  • Device: RenalGuard Therapy
  • Drug: Standard Therapy

Specialties

  • Internal Medicine: Nephrology/Urology
  • Nursing: Nephrology/Urology
  • Nephrology: Nephropathies
  • Physician Assistant: Nephrology

MeSH Terms

  • Kidney Diseases
  • Urologic Diseases

Study ID

PLC Medical Systems, Inc. -- RGS001D

Status

Unknown

Trial ID

NCT01456013

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

326

Sponsor

PLC Medical Systems, Inc.

Inclusion Criteria

  • Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
  • Subject is scheduled to undergo an elective catheterization procedure
  • Hemodynamically stable
  • At increased risk of developing CIN
  • Subject has agreed to all follow-up testing.

Exclusion Criteria

  • Class 3 or 4 Congestive Heart Failure (CHF)
  • Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed.
  • Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
  • Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
  • Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
  • Patient has moderate to severe anemia (hematocrit < 27%) at screening
  • Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
  • Has ruled in for an Acute Myocardial Infarction within 48 hours of the planned procedure
  • Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
  • Planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
  • Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
  • Subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
  • Subject is pregnant or breastfeeding.
  • Subject is unable to provide informed consent.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
St Elizabeths Hospital - Brighton, Massachusetts 2.4 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
The Miriam Hospital - Providence, Rhode Island 39.6 miles None None None
The Miriam Hospital - Providence, Rhode Island 39.6 miles Lori DeSimone RN None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles Maria Medeiros RN None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Cape Cod Healthcare - Hyannis, Massachusetts 64.6 miles None None None
Hartford Hospital - Hartford, Connecticut 92.3 miles None None None
Hartford Hospital - Hartford, Connecticut 92.3 miles None None None
Stony Brook University Medical Center - Stony Brook, New York 145.7 miles None None None
Mount Sinai Medical Center - NY, New York 183.2 miles Laura Ramirez None None
Mount Sinai Medical Center - NY, New York 183.2 miles None None None
NYU Medical Center - New York, New York 186.5 miles None None None
Guthrie Medical Center - Sayre, Pennsylvania 279.7 miles None None None
Guthrie Medical Center - Sayre, Pennsylvania 279.7 miles None None None
Washington Hospital Center - Washington, District of Columbia 391.7 miles None None None
Washington Hospital Center - Washington, District of Columbia 391.7 miles None None None
Allegheny General Hospital - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny General Hospital - Pittsburgh, Pennsylvania 480.9 miles None None None
Beaumont Heart Center - Royal Oak, Michigan 616.2 miles None None None
Beaumont Heart Center - Royal Oak, Michigan 616.2 miles None None None
Northwestern Memorial Hospital - Chicago, Illinois 847.9 miles None None None
St Joseph Medical Center - St. Charles, Missouri 1,045.1 miles None None None
Swedish Medical Center - Seattle, Washington 2,488.3 miles None None None

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