Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
NCT01160627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720
Last updated 2013-03-22
Summary
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.
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
Conditions
- Contrast Induced Nephropathy
Interventions
- OTHER
-
Hydration
Saline hydration
- DRUG
-
Acetylcysteine
Acetylcystein tablets for 2 days
- DRUG
-
Sodium bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
- DRUG
-
Combined Acetylcystein and Sodium Bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Sponsors & Collaborators
-
Odense University Hospital
lead OTHER
Principal Investigators
-
Per Thayssen, MD DMSci · Odense University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- Denmark
Study Locations
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