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MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223548
First Posted: September 22, 2005
Last Update Posted: September 22, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Ulm
September 14, 2005
September 22, 2005
September 22, 2005
October 2002
Not Provided
Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
Same as current
No Changes Posted
Need for dialysis after the administration of contrast media.
Same as current
Not Provided
Not Provided
 
MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.

The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Chronic Renal Insufficiency
  • Serum Creatinine Concentration
  • Contrast Media Exposition
Drug: sodium 2-mercaptoethane sulfonate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 2004
Not Provided

Inclusion Criteria:

  • stable chronic renal insufficiency
  • serum creatinine concentration > 1,5 mg/dl

Exclusion Criteria:

  • Dialyzed patients
  • patients with acute renal failure
  • received iodinated contrast media within 7 days before study entry
  • known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00223548
A119/2002
Not Provided
Not Provided
Not Provided
Not Provided
University of Ulm
Not Provided
Principal Investigator: Frieder Keller, M.D. Division of Nephrology, University Hospital Ulm
Principal Investigator: Frieder Keller, M.D. Division of Nephrology, University Hospital of Ulm
University of Ulm
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP