A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

Detailed Description
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It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.

Official Title
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A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization

Conditions
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Nephropathy

Intervention / Treatment
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* Drug: Oral N-Acetylcysteine
* Drug: Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years of age Baseline serum creatinine or Calculated creatinine Stable Renal Function Left Ventricular ejection fraction Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required Able to sign informed consent Exclusion Criteria: Acute renal failure History of Kidney transplant Currently receiving N-acetylcysteine _ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate Left ventricular ejection fraction Pregnant, lactating females Allergy to contrast dye

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-Acetylcysteine<br>Oral N-Acetylcysteine 600 mg | Drug: Oral N-Acetylcysteine<br>* 600 milligrams (mg)<br>* Other names: N-Acetyl-L-Cysteine;|
| Active Comparator: Sodium Bicarbonate<br>Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure | Drug: Sodium Bicarbonate<br>* 3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure<br>* Other names: baking soda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy | Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast induced nephropathy