Back to resultsMESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
Primary Purpose
Chronic Renal Insufficiency, Serum Creatinine Concentration, Contrast Media Exposition
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
sodium 2-mercaptoethane sulfonate
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Renal Insufficiency focused on measuring prophylaxis, contrast-induced nephropathy, mesna, acute renal failure
Eligibility 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
Sites / Locations
- Division of Nephrology, University of Ulm
Outcomes
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.
Full Information
NCT ID
NCT00223548
First Posted
September 14, 2005
Last Updated
September 14, 2005
Sponsor
University of Ulm
1. Study Identification
Unique Protocol Identification Number
NCT00223548
Brief Title
MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
Official Title
MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
Study Type
Interventional
2. Study Status
Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Serum Creatinine Concentration, Contrast Media Exposition
Keywords
prophylaxis, contrast-induced nephropathy, mesna, acute renal failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
106 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sodium 2-mercaptoethane sulfonate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Need for dialysis after the administration of contrast media.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frieder Keller, M.D.
Organizational Affiliation
Division of Nephrology, University Hospital Ulm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frieder Keller, M.D.
Organizational Affiliation
Division of Nephrology, University Hospital of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Nephrology, University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application
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