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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: December 9, 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
  Purpose
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Condition Intervention Phase
Chronic Renal Insufficiency Serum Creatinine Concentration Contrast Media Exposition Drug: sodium 2-mercaptoethane sulfonate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Need for dialysis after the administration of contrast media.

Estimated Enrollment: 106
Study Start Date: October 2002
Estimated Study Completion Date: December 2004
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223548


Locations
Germany
Division of Nephrology, University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00223548     History of Changes
Other Study ID Numbers: A119/2002
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2002

Keywords provided by University of Ulm:
prophylaxis
contrast-induced nephropathy
mesna
acute renal failure

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Mesna
Protective Agents
Physiological Effects of Drugs