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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-01

Study Completion Date

2010-04-08

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.

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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.

Conditions

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Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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N-Acetylcysteine

Oral N-Acetylcysteine 600 mg

Group Type ACTIVE_COMPARATOR

Oral N-Acetylcysteine

Intervention Type DRUG

600 milligrams (mg)

Sodium Bicarbonate

Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure

Group Type ACTIVE_COMPARATOR

Sodium Bicarbonate

Intervention Type DRUG

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

Interventions

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Oral N-Acetylcysteine

600 milligrams (mg)

Intervention Type DRUG

Sodium Bicarbonate

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

Intervention Type DRUG

Other Intervention Names

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N-Acetyl-L-Cysteine Sodium hydrogen carbonate sodium acid carbonate baking soda

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes