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

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00223548
First received: September 14, 2005
Last updated: NA
Last verified: September 2002
History: No changes posted

September 14, 2005
September 14, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00223548
A119/2002
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