The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

Study Overview
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Brief Summary
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The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography

Official Title
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The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

Conditions
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Contrast-induced Acute Kidney Injury, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Indications for computer tomography with intravenous contrast media administration Cardiovascular diseases (arterial hypertension, arrhythmia etc) Exclusion Criteria: Pregnancy Statin therapy before inclusion in the study Acute coronary syndromes Contraindications for statins administration Patients with chronic kidney disease stages 4-5 Contraindications for computer tomography with contrast media administration Nephrotoxic drugs use (NSAIDS, vancomycin etc)

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>No statins being used for prevention | Drug: Atorvastatin<br>* To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration<br>|
| Active Comparator: Low-dose statin therapy<br>Atorvastatin 40 mg | Drug: Atorvastatin<br>* To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration<br>|
| Active Comparator: High-dose statin therapy<br>Atorvastatin 80 mg | Drug: Atorvastatin<br>* To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced acute kidney injury | Contrast induced acute kidney injury is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media. | 48-72 hours after contrast media administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-induced acute kidney injury, contrast-associated acute kidney injury, contrast media, cardiovascular diseases, computer tomography