Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.

Study Overview
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Brief Summary
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This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.

Detailed Description
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This study enrolled 150 patients planned for CC, and randomly assigned for one of the three groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C) include 47 patients who only hydrated with saline. All included patients were hydrated with saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC. Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.

Official Title
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Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization

Conditions
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Contrast-induced Nephropathy

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Carvedilol
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 70 years. Serum creatinine ≤ 1.5 mg/dL. Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins). Moderate to high-risk for CIN. Exclusion Criteria: Patients suffering from ST-segment elevation myocardial infarction (STEMI) Patients need for immediate cardiac catheterization Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal). Active infection. Any contraindication to carvedilol, or atorvastatin. Patients on regular use of vitamins, minerals. Using medication with antioxidant properties e.g., beta-carotene, vitamin E, vitamin C, selenium, theophylline or N-acetyl cysteine 7 days prior to CC. Hemodynamically unstable patients (defined as abnormal or unstable blood pressure, especially hypotension (blood pressure less than 90/60 mm Hg). Patients who required dialysis. Pregnancy. Using of carvedilol in the past three months. Using a nephrotoxic agent in the past 48 hours or exposure to a contrast agent in the past 7 days prior to cardiac catheterization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (A)<br>included 49 patients who received high dose statin (80 mg atorvastatin) 12 hours before CC and 40 mg just before CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. | Drug: Atorvastatin<br> <br> Drug: saline<br> <br> * Other names: 0.9%NaCl;|
| Experimental: Group (B)<br>included 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continued for 24 hours after the CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. | Drug: Carvedilol<br> <br> Drug: saline<br> <br> * Other names: 0.9%NaCl;|
| Experimental: Group (C)<br>included 47 patients who did not receive any medications but only hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization | Drug: saline<br> <br> * Other names: 0.9%NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of contrast induced nephropathy | CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC). | 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Glomerular filtration rate (eGFR) | Cockcroft-Gault equation was used to calculate (eGFR) | on admission, and re-calculated 48 hours post CC using | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac catheterization, carvedilol, atorvastatin.