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

NCT ID: NCT00223548

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Renal Insufficiency Serum Creatinine Concentration Contrast Media Exposition

Keywords

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prophylaxis contrast-induced nephropathy mesna acute renal failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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sodium 2-mercaptoethane sulfonate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Principal Investigators

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Frieder Keller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, University Hospital Ulm

Frieder Keller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, University Hospital of Ulm

Locations

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Division of Nephrology, University of Ulm

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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A119/2002

Identifier Type: -

Identifier Source: org_study_id