Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.

Detailed Description
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Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.

Official Title
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Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Drug: alpha tocopherol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study) Exclusion Criteria: patients with acute kidney injury end stage renal disease (requiring dialysis) unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study) allergy to any of the contrast agents mechanical ventilation suffered from congestive heart failure, cardiogenic shock or emergent angiography. receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alpha tocopherol<br> | Drug: alpha tocopherol<br>* The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.<br>* Other names: Bio-E-vitamin;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.<br>* Other names: jelly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha-Tocopherol (Vitamin E), Contrast induced nephropathy, Chronic kidney disease, Coronary procedures