Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy (CIN) Prevention (MYTHOS)
Recruitment status was: Recruiting
|Contrast Induced Nephropathy||Drug: Furosemide and matched saline hydration Drug: isotonic saline solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Study to Evaluate the Effectiveness of Induced Diuresis With Matched Hydration Therapy Compared to Standard Overnight Hydration in the Prevention of Contrast Induced Nephropathy -MYTHOS Study|
- Incidence of CIN [ Time Frame: 48-72 hours ]
- Blood chemistry, major adverse clinical events, safety [ Time Frame: Hospitalizatiojn period ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Furosemide and matched saline hydration by RenalGuard system
Drug: Furosemide and matched saline hydration
Subjects will begin treatment approximately 90 minutes prior to the start of catheterization procedure. After a pre-hydration bolus of 250 ml of normal saline solution over 30 minutes the patient will receive 0.5 mg/kg of furosemide intravenously. Then, a replacement solution (saline) is given in an amount matched (ml for ml) to the volume of urine produced. Matched hydration will occur prior, during, and 4 hours post procedure.
Active Comparator: 2
Standard IV saline infusion
Drug: isotonic saline solution
Subjects will receive 1 ml/Kg/hr of intravenous saline solution for a minimum of 12 hours prior to catheterization. Hydration will continue to occur during the catheterization, and for a minimum of 12 hours post catheterization.
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. CIN is one of the most important adverse effects of contrast agents, and can cause substantial morbidity and mortality.
Although the exact mechanisms remain unknown, intravenous hydration before the catheterization procedure is the only current treatment that has been shown to reduce the incidence of CIN. However, in patients with baseline impairments in renal function, hydration is commonly performed at a rate significantly lower than that shown to provide protection due to the fear of overhydration and pulmonary edema. Previous studies have used diuretics to increase urine output and prevent overhydration. In addition to the benefit of increased urine flow, loop diuretics, such as furosemide, should be expected to provide additive benefit against another potential mechanism of CIN, medullary ischemia, as they reduce sodium reabsorption, and consequentially oxygen consumption, of the kidney. While the results of their use have been mixed, it appears that furosemide was deleterious in patients who became dehydrated, i.e. those in whom the urine output was substantially greater than the rate of hydration they received.
This problem may be overcome by a device, which is now available on the market, called the RenalGuard System. The System is capable of delivering saline 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 or fluid overload.The aim of the study is to compare furosemide-induced diuresis with matched hydration therapy compared to standard hydration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702728
|Contact: Antonio L Bartorelli, MD||39-02-58002 ext email@example.com|
|Contact: Giancarlo Marenzi, MD||39-02-58002 ext firstname.lastname@example.org|
|Centro Cardiologico Monzino- University of Milan||Recruiting|
|Milan, Italy, 20138|
|Contact: Antonio L Bartorelli, MD 39-02-58002 ext 331 email@example.com|
|Contact: Giancarlo Marenzi, MD 39-02-58002 ext 582 firstname.lastname@example.org|
|Sub-Investigator: Cristina Ferrari, MD|
|Principal Investigator:||Antonio L Bartorelli, MD||University of Milan|