Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy (CIN) Prevention (MYTHOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Centro Cardiologico Monzino.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00702728
First received: June 11, 2008
Last updated: October 9, 2009
Last verified: June 2008
  Purpose

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
Contrast Induced Nephropathy
Drug: Furosemide and matched saline hydration
Drug: isotonic saline solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • Incidence of CIN [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood chemistry, major adverse clinical events, safety [ Time Frame: Hospitalizatiojn period ] [ Designated as safety issue: Yes ]

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
Experimental: 1
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant female equal or greater than the age of 18 years old.
  2. 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.
  3. Subject is clinically stable for >24hrs defined as Killip Class 1
  4. Baseline Renal Function eGFR < 60ml/min, by MDRD (Modification of Diet in Renal Disease) calculator.
  5. Patient has agreed to all follow-up testing.

Exclusion Criteria:

  1. Catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries.
  2. Requires emergent catheterization or primary percutaneous intervention.
  3. Subject is anuric, has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month.
  4. Known inability to place a Foley catheter
  5. Currently has a known electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
  6. Has received intravenous contrast within 10 days of procedure or has a planned procedure using contrast within 72 hours following the procedure.
  7. Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
  8. Currently receiving or expected to receive Mannitol or Lithium therapy
  9. Planned addition, discontinuation or dose adjustment of the trimethoprim, cimetidine, metaclopramide and/or the use of non-steroidal anti-inflammatory drugs within 48 hours of the procedure.
  10. Subject has a known hypersensitivity to furosemide.
  11. 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.
  12. If female, subject is pregnant or breastfeeding.
  13. Subject is unable to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702728

Contacts
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

Locations
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         
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Antonio L Bartorelli, MD University of Milan
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antonio Bartorelli, M.D., Centro Cardiologico Monzino- University of Milan
ClinicalTrials.gov Identifier: NCT00702728     History of Changes
Other Study ID Numbers: R100-CCFM S103/208, EUDRACT No: 2008-001200-23
Study First Received: June 11, 2008
Last Updated: October 9, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
Contrast induced nephropathy
Furosemide
Percutaneous coronary interventions
Saline hydration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Furosemide
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014