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Sponsors and Collaborators: |
University of Milan Centro Cardiologico Monzino |
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Information provided by: | University of Milan |
ClinicalTrials.gov Identifier: | NCT00702728 |
This study is being proposed with the objective to assess the potential benefits of induced diuresis by furosemide with matched hydration therapy compared to standard hydration in the prevention of contrast-induced nephropathy (CIN). It is expected that matched hydration will prove to be as effective as hydration alone, will avoid an overnight stay prior to the procedure, and thus will prove to be a less costly and more clinically manageable solution to the prevention of CIN.
Condition | Intervention | Phase |
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Contrast Induced Nephropathy |
Drug: Furosemide and matched saline hydration Drug: isotonic saline solution |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 120 |
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) |
Arms | Assigned Interventions |
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1: Experimental
Furosemide and matched saline hydration by RenalGuard system
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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.
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2: Active Comparator
Standard IV saline infusion
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Scheduled to undergo a non-emergent catheterization procedure with anticipated to use ≥80 ml contrast media.
Additional other procedure (e.g., left ventriculography, imaging of grafts, stenting, etc.) are allowable other than those listed below as exclusion criteria #1.
Exclusion Criteria:
Contact: Antonio L Bartorelli, MD | 39-02-58002 ext 331 | antonio.bartorelli@ccfm.it |
Contact: Giancarlo Marenzi, MD | 39-02-58002 ext 582 | giancarlo.marenzi@ccfm.it |
Italy | |
Centro Cardiologico Monzino- University of Milan | Recruiting |
Milan, Italy, 20138 | |
Contact: Antonio L Bartorelli, MD 39-02-58002 ext 331 antonio.bartorelli@ccfm.it | |
Contact: Giancarlo Marenzi, MD 39-02-58002 ext 582 giancarlo.marenzi@ccfm.it | |
Sub-Investigator: Cristina Ferrari, MD |
Principal Investigator: | Antonio L Bartorelli, MD | University of Milan |
Responsible Party: | Centro Cardiologico Monzino- University of Milan ( Antonio Bartorelli, M.D. ) |
Study ID Numbers: | R100-CCFM S103/208, EUDRACT No: 2008-001200-23 |
Study First Received: | June 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00702728 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Contrast induced nephropathy Furosemide Percutaneous coronary interventions Saline hydration |
Urologic Diseases Diuretics Cardiovascular Agents |
Kidney Diseases Sodium Potassium Chloride Symporter Inhibitors Furosemide |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Urologic Diseases Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Kidney Diseases Sodium Potassium Chloride Symporter Inhibitors Furosemide Pharmacologic Actions |