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

September 14, 2005 updated by: University of Ulm

MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie

The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • Division of Nephrology, University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Need for dialysis after the administration of contrast media.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 14, 2005

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A119/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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