RENALGUARD: 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
ID Number 11-1417Principal Investigator(s)
Michael C. Kim
Department(s) or Division(s)
The Zena and Michael A. Wiener Cardiovascular Institute
The purpose of this study is to determine if a new treatment, called induced diuresis (making the kidneys produce more urine than usual) with matched hydration, (fluid replacement) is a safe and potentially effective way to protect patients' kidneys during their catheterization procedure. Due to the patients' existing impaired kidney function, some patients may be at a higher risk for developing contrast induced nephropathy (CIN), which is kidney damage caused by exposure to the contrast agent used during the catheterization procedure. Physicians believe that CIN can lead to further medical problems both right after the catheterization and in the future.
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 purpose of this matched fluid replacement is to prevent hypovolemia that may lead to hypotension and vital organ dysfunction, or fluid overload that may lead to shortness of breath in patients in whom high urine output is desired, such as those undergoing procedures using contrast media. 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.
This is a multicenter study. The total number of enrollment for all sites is 326, and subjects are to be randomized 1:1. The total number to be enrolled at Mount Sinai is 25. Patient participation will consist of an approximately 8-10 hour treatment period, five short term follow-up assessments, and one long term assessment at 90 days post catheterization procedure. The total study duration is not expected to exceed 3 years.
Recruiting Patients: Yes