Status:
UNKNOWN
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
Lead Sponsor:
CardioRenal Systems, Inc.
Conditions:
Contrast Induced Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Class 4 Congestive Heart Failure (CHF)or a documented left ventricular ejection fraction \< 30%
- 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 severe anemia (hemoglobin \< 8.0 g/dL) at screening
- Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the 7 day follow-up period.
- Has ruled in for a Serious Heart Attack 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 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT01456013
Start Date
January 1 2012
End Date
December 1 2024
Last Update
February 16 2023
Active Locations (30)
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1
University of Alabama
Birmingham, Alabama, United States, 35924
2
Torrance Medical Center
Torrance, California, United States, 90505
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Clearwater Cardiovascular
Clearwater, Florida, United States, 33756