Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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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: Standard treatment Standard treatment + acetylcystein for 2 days Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours

Official Title
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Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Other: Hydration
* Drug: Acetylcysteine
* Drug: Sodium bicarbonate
* Drug: Combined Acetylcystein and Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI patients treated with primary PCI Exclusion Criteria: Cardiogenic shock

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>Hydration | Other: Hydration<br>* Saline hydration<br>|
| Active Comparator: Combined Acetylcystein and Sodium Bicarbonat<br> | Drug: Combined Acetylcystein and Sodium Bicarbonate<br>* Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days<br>|
| Active Comparator: Sodium Bicarbonate<br> | Drug: Sodium bicarbonate<br>* Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours<br>|
| Active Comparator: Acetylcystein for 2 days<br>Standard treatment + acetylcystein for 2 days | Drug: Acetylcysteine<br>* Acetylcystein tablets for 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI | Rise in creatinine >25% from baseline to day 3 | from baseline to day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI | Rise in creatinine >25% from baseline to day 30 | from baseline to day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIN STEMI