MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
Information source: University of Ulm
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Renal Insufficiency; Serum Creatinine Concentration; Contrast Media Exposition
Intervention: sodium 2-mercaptoethane sulfonate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Frieder Keller, M.D., Principal Investigator, Affiliation: Division of Nephrology, University Hospital Ulm
Frieder Keller, M.D., Principal Investigator, Affiliation: Division of Nephrology, University Hospital of Ulm
Summary
The purpose of this study is to determine wether Mesna could prevent contrast-induced
nephropathy
Clinical Details
Official title: MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: Need for dialysis after the administration of contrast media.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Division of Nephrology, University of Ulm, Ulm 89081, Germany
Additional Information
Starting date: October 2002
Ending date: December 2004
Last updated: September 14, 2005
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