RenalGuard Trial Physician

The Miriam Hospital  
Lori-Ann DeSimone

Rhode Island Hospital
Cardiac Projects Office 

Rhode Island Hospital/The Miriam Hospital

A Study to Evaluate RenalGuard™ System Safety and Efficacy when Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory

Radiocontrast agents (contrast) are widely used in coronary and peripheral vascular catheterization procedures. Although the use of these iodine-containing agents is vital for these procedures, it can be associated with adverse side effects. Contrast Induced Nephropathy (CIN) is one of the most important adverse effects of contrast agents, and can cause substantial morbidity and mortality. The incidence of CIN is estimated at 150,000 cases per year of the more than four million radiocontrast procedures performed annually. Approximately 1% of CIN cases necessitate hemodialysis treatment and an average prolonged hospital length of stay of 17 days, resulting in an additional cost of millions of dollars per year. Although the exact mechanisms remain unknown, intravenous/oral hydration is the only current treatment that has been shown to reduce the incidence of CIN.

The investigational device being studied is called The RENALGUARD®System (The System). The System is capable of delivering sterile replacement solution to a patient in an amount matched to the volume of urine produced by the patient. The device is intended to be used in a monitored hospital environment such as a step-down unit or a catheterization laboratory by medical personnel trained in the use of the device. The primary objective of this clinical trial is to evaluate whether the RenalGuard Therapy is superior to a well-studied standard hydration protocol for preventing the incidence of (CIN) after a catheterization procedure which uses iodinated contrast media.

Inclusion Criteria
1.     Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
2.     Subject is scheduled to undergo an elective catheterization procedure that is expected to use at least75ml of intravenous contrast. Additional other procedures (e.g., left ventriculography, imaging of grafts, stenting, etc.) are allowable except those procedures requiring a direct renal injection of contrast or injection into the descending aorta proximal to the renal arteries.
3.     Hemodynamically stable defined as: SBP < 160 and DBP < 100 on a stable medical regimen AND SBP > 100 without vasopressor or inotropic support (except for digoxin).
4.     Subject has moderate to severe kidney impairment- eGFR (from abbreviated MDRD): ≥15 and ≤45 or eGFR >45 and ≤60 with two or more of the following risk factors:
- Diabetes
- Age ≥ 75 years
- Proteinuria
5.     Subject has agreed to all follow-up testing.

Exclusion Criteria
1.     New onset of class 3 or 4 congestive heart failure within 72 hours of the study, pre-existing class 3 or 4 chronic stable heart failure or a documented left ventricular ejection fraction < 35%
2.     Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed.
3.     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.
4.     Subject has a documented history of severe aortic stenosis, defined as an aortic valve area of < 1cm2, with or without symptoms. (Note: Subjects who have undergone successful replacement or repair of his/her aortic valve are not excluded.)
5.     Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject’s hemodynamic state.
6.     Patient has moderate to severe anemia (hematocrit < 27%) at screening
7.     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.
8.     Has ruled in for an ST-Elevation Myocardial Infarction (STEMI) within 48 hours of the planned procedure by relevant ECG changes and blood testing (blood test positive for cardiac biomarkers)
9.     Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
10.     Planned addition, discontinuation or dose adjustment of the trimethoprim, cimetidine, metaclopramide, ACE Inhibitors, ARB, fenoldopam, dopamine, vancomycin, non-steroidal anti-inflammatory drugs or any other known renal toxic medications. Chronic use of these medications is not excluded.
11.     Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
12.     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.
13.     Subject is pregnant or breastfeeding.
14.     Subject is unable to provide informed consent.