Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
NCT ID: NCT01160627
Last Updated: 2013-03-22
Study Results
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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COMPLETED
NA
720 participants
INTERVENTIONAL
2010-04-30
2013-03-31
Brief Summary
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DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.
Patients will be randomised to:
1. Standard treatment
2. Standard treatment + acetylcystein for 2 days
3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Standard treatment
Hydration
Hydration
Saline hydration
Combined Acetylcystein and Sodium Bicarbonat
Combined Acetylcystein and Sodium Bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Sodium Bicarbonate
Sodium bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Acetylcystein for 2 days
Standard treatment + acetylcystein for 2 days
Acetylcysteine
Acetylcystein tablets for 2 days
Interventions
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Hydration
Saline hydration
Acetylcysteine
Acetylcystein tablets for 2 days
Sodium bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Combined Acetylcystein and Sodium Bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Lisette Okkels Jensen
MD DMSci PhD
Principal Investigators
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Per Thayssen, MD DMSci
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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References
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Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
Other Identifiers
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CIN in STEMI
Identifier Type: -
Identifier Source: org_study_id
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