NCT00702728

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 12, 2009

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 11, 2008

Last Update Submit

October 9, 2009

Conditions

Contrast Induced Nephropathy

Keywords

Contrast induced nephropathyFurosemidePercutaneous coronary interventionsSaline hydration

Outcome Measures

Primary Outcomes (1)

  • Incidence of CIN

    48-72 hours

Secondary Outcomes (1)

  • Blood chemistry, major adverse clinical events, safety

    Hospitalizatiojn period

Study Arms (2)

1

EXPERIMENTAL

Furosemide and matched saline hydration by RenalGuard system

Drug: Furosemide and matched saline hydration

2

ACTIVE COMPARATOR

Standard IV saline infusion

Drug: isotonic saline solution

Interventions

Furosemide and matched saline hydrationDRUG

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.

1
isotonic saline solutionDRUG

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female equal or greater than the age of 18 years old.

You may not qualify if:

  • Subject is clinically stable for \>24hrs defined as Killip Class 1
  • Baseline Renal Function eGFR \< 60ml/min, by MDRD (Modification of Diet in Renal Disease) calculator.
  • Patient has agreed to all follow-up testing.
  • Catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries.
  • Requires emergent catheterization or primary percutaneous intervention.
  • 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.
  • Known inability to place a Foley catheter
  • Currently has a known electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
  • Has received intravenous contrast within 10 days of procedure or has a planned procedure using contrast within 72 hours following the procedure.
  • Has documented respiratory insufficiency as evidenced by an oxygen saturation of \< 90% on room air assessed on day of procedure.
  • Currently receiving or expected to receive Mannitol or Lithium therapy
  • 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.
  • Subject has a known hypersensitivity to furosemide.
  • 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.
  • If female, subject is pregnant or breastfeeding.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino- University of Milan

Milan, 20138, Italy

RECRUITING

Related Publications (6)

  • Marenzi G, Marana I, Lauri G, Assanelli E, Grazi M, Campodonico J, Trabattoni D, Fabbiocchi F, Montorsi P, Bartorelli AL. The prevention of radiocontrast-agent-induced nephropathy by hemofiltration. N Engl J Med. 2003 Oct 2;349(14):1333-40. doi: 10.1056/NEJMoa023204.

    PMID: 14523141BACKGROUND

  • Mueller C, Buerkle G, Buettner HJ, Petersen J, Perruchoud AP, Eriksson U, Marsch S, Roskamm H. Prevention of contrast media-associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty. Arch Intern Med. 2002 Feb 11;162(3):329-36. doi: 10.1001/archinte.162.3.329.

    PMID: 11822926BACKGROUND

  • Solomon R, Werner C, Mann D, D'Elia J, Silva P. Effects of saline, mannitol, and furosemide on acute decreases in renal function induced by radiocontrast agents. N Engl J Med. 1994 Nov 24;331(21):1416-20. doi: 10.1056/NEJM199411243312104.

    PMID: 7969280BACKGROUND

  • Marenzi G, Lauri G, Campodonico J, Marana I, Assanelli E, De Metrio M, Grazi M, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Comparison of two hemofiltration protocols for prevention of contrast-induced nephropathy in high-risk patients. Am J Med. 2006 Feb;119(2):155-62. doi: 10.1016/j.amjmed.2005.08.002.

    PMID: 16443418BACKGROUND

  • Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

    PMID: 39878152DERIVED

  • Marenzi G, Ferrari C, Marana I, Assanelli E, De Metrio M, Teruzzi G, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention) trial. JACC Cardiovasc Interv. 2012 Jan;5(1):90-7. doi: 10.1016/j.jcin.2011.08.017.

    PMID: 22230154DERIVED

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Antonio L Bartorelli, MD

    University of Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio L Bartorelli, MD

CONTACT

39-02-58002antonio.bartorelli@ccfm.it

Giancarlo Marenzi, MD

CONTACT

39-02-58002giancarlo.marenzi@ccfm.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

October 12, 2009

Record last verified: 2008-06

Locations

IT(1)