A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory

Status: Unknown
Location: See all (30) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama
Birmingham
California
Torrance Medical Center
Torrance
Washington, D.c.
Washington Hospital Center
Washington
Florida
Clearwater Cardiovascular
Clearwater
University of Florida
Jacksonville
Illinois
Northwestern Memorial Hospital
Chicago
Advocate Good Samaritan
Downers Grove
Advocate Health
Naperville
Massachusetts
St. Elizabeth's Hospital
Brighton
Cape Cod Healthcare
Hyannis
University of Massachusetts
Worcester
Maryland
Johns Hopkins University
Baltimore
Michigan
Northern Michigan Hospital
Petoskey
Minnesota
Abbott Northwestern
Minneapolis
Missouri
St. Joseph Medical Center
Saint Charles
Mississippi
North Mississippi Medical Center
Tupelo
North Carolina
Rex Hospital
Raleigh
New York
Columbia University
New York
Montefiore Medical Center
New York
Mount Sinai Medical Center
New York
NYU Medical Center
New York
Stony Brook University Medical Center
Stony Brook
Oklahoma
St. John Research Institute
Bartlesville
Pennsylvania
University of Pittsburgh
Pittsburgh
Guthrie Medical Center
Sayre
Rhode Island
Rhode Island Hospital
Providence
The Miriam Hospital
Providence
Texas
Austin Heart Central
Austin
Baylor Scott & White
Plano
Austin Heart Round Rock
Round Rock
Time Frame
Start Date: 2012-01
Completion Date: 2024-12
Participants
Target number of participants: 326
Treatments
Active_comparator: Standard Therapy
Standard of care for patients at risk of CIN
Experimental: RenalGuard Therapy
Induced Diuresis with Matched Replacement
Sponsors
Leads: CardioRenal Systems, Inc.

This content was sourced from clinicaltrials.gov