Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CardioRenal Systems, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
